Oncology

Posted 2 months ago by Wales Gene Park

The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms.

 Medulloblastoma /  London

Posted 2 months ago by Wales Gene Park

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC including an embedded sub-study for R1 resected patients receiving additional chemoradiation.

 Bile Duct Cancers /  Velindre Cancer Centre

Posted 2 months ago by Wales Gene Park

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

 Bile Duct Cancers /  Velindre Cancer Centre

Posted 2 months ago by Wales Gene Park

The purpose of this study is to test the safety and efficacy of AUTO4 a CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma.

 Anaplastic Large Cell Lymphoma /  England

Posted 2 months ago by Wales Gene Park

High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.

 Colorectal cancers /  London

Posted 2 months ago by Wales Gene Park

The main purpose of this study is : To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with...

 Acute myeloid leukaemia /  Noah's Ark Children's Hospital for Wales

Posted 2 months ago by Wales Gene Park

The current national acute lymphoblastic leukaemia (ALL) trial in adults investigated whether a low (reduced) intensity chemotherapy regimen prior to transplant could improve the outcome of patients with ALL who are over 40 years of age. The results (60% 2 year survival) are very encouraging but patients who come to transplant with small amounts of 'residual' disease had less good outcomes. The goal of this trial is to see if a slightly stronger chemotherapy regimen (involving total body irradiation, (TBI)) can improve results by reducing the chance of the disease coming back (relapsing) without increasing the chance of not surviving the transplant. Up to 242 patients will be 'randomised' to the trial to receive either the established chemotherapy of fludarabine and melphalan or cyclophosphamide and TBI to compare the outcomes between the two treatment regimens. Other measures to reduce relapse will be the earlier use of donor white cell infusions...

 Acute lymphoblastic leukaemia (ALL)

Posted 2 months ago by Wales Gene Park

This study will evaluate a new maintenance therapy with the aim of improving the outcome of patients with acute myeloid leukaemia (AML) and myelodysplasia (MDS) after stem cell transplantation.

 Acute myeloid leukaemia

Posted 2 months ago by Wales Gene Park

The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).

 Acute myeloid leukaemia

Posted 2 months ago by Wales Gene Park

The primary objectives of this study are: To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate

 Acute myeloid leukaemia

Posted 2 months ago by Wales Gene Park

High blood pressure (hypertension) causes strokes and heart attacks. While most patients need long-term treatment with pills, some have a cause which can be removed, curing the hypertension. The commonest curable cause is a benign nodule in one of the hormone glands, the adrenals. About one in 20 patients have such a nodule, but difficulties with diagnosis, and reluctance to proceed to surgery for a bengin condition, limit the number having adrenal gland surgery to fewer than 300 per year in the UK. A potential, and exciting, solution to this dilemma is to use a momentary electric current to cauterise the nodule (radiofrequency ablation), without affecting the rest of the adrenal gland, and avoiding the need for surgery. Nodules in the left adrenal gland are easily reached under mild sedation using a similar procedure as is standard for investigating stomach ulcers (endoscopy). The study is designed to show that this...

 Adrenal Adenoma

Posted 2 months ago by Wales Gene Park

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.

 Acute myeloid leukaemia

Posted 3 months ago by Wales Gene Park

An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

 Acute myeloid leukaemia

Posted 3 months ago by Wales Gene Park

DICE is a randomised study recruiting 126 women over 3 years from hospitals in the UK and Germany. Eligible patients will have tissue based diagnosis of advanced/recurrent ovarian cancer (clear cell, endometrioid or high grade serous or carcinosarcoma), have had chemotherapy before, and be platinum-resistant (the cancer has returned/grown significantly during or within 6 months of platinum-containing chemotherapy).

 Gynaecological Cancer

Posted 3 months ago by Wales Gene Park

The AML18 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years considered fit for an intensive chemotherapeutic approach, but younger patients who may not be considered suitable for the concurrent NCRI AML Trial for younger patients may also enter. Patients for whom intensive chemotherapy is not thought suitable may enter the concurrent NCRI trial of less intensive therapy (LI1). Approximately 1600 patients will be recruited. At entry, a randomisation will compare a standard chemotherapy schedule DA (Daunorubicin/Ara-C) combined with 1 dose of Mylotarg (gemtuzumab ozogamicin, or GO) in course 1 against CPX-351. Patients who have known adverse risk cytogenetics (using Grimwade 2010 classification favourable/intermediate/adverse) at diagnosis may enter a Phase 2 evaluation of the combination of Vosaroxin plus Decitabine. Patients who achieve complete remission (CR) and who...

 Acute myeloid leukaemia /  University Hospital of Wales

Posted 2 years ago by Wales Gene Park

CHEMORES: A study to understand more about why chemotherapy to treat lung cancer can stop working This study will look for changes in blood and tissue samples before and after treatment for lung cancer, to try to find out how cancer cells stop themselves being harmed by treatment. Doctors may use surgery, radiotherapy, chemotherapy or another type of drug that targets lung cancer to treat this disease. Your treatment will depend on your type and stage of lung cancer. If you have non small cell lung cancer, you may have a combination of these. If you have small cell lung cancer, you would usually have chemotherapy. We know from research that cancer cells can become 'resistant’ to treatment. In lung cancer for example, cancer cells can sometimes reduce the concentration of the drug inside them, and repair DNA damage. And, develop changes in the genes in cancer cells that prevent the treatment from working. Understanding why resistance happens will help develop improved...

 Small cell lung cancer /  Manchester

Posted 2 years ago by Wales Gene Park

This study is looking at blood samples to find out more about the genetic causes of kidney cancer. There are many risk factors associated with developing renal cell carcinoma (RCC). This is the most common form of kidney cancer. There are some faulty genes and inherited conditions that increase risk. This study is looking at people who may have an inherited genetic fault or medical condition that increases their risk of developing RCC. The aim of the study is to find out more about the genetic causes of RCC, and more about how gene faults may increase risk.

 Rare Kidney Cancers /  England

Posted 2 years ago by Wales Gene Park

PETReA: A study to find out whether a PET-CT scan can help to tell who needs to have rituximab after the initial treatment for lymphoma. Follicular Lymphoma is a type of non Hodgkin lymphoma (NHL). Doctors usually put NHL into 2 groups, depending on how likely they are to grow and spread. The 2 groups are low grade and high grade NHL. Follicular lymphoma is a type of low grade NHL. For follicular lymphoma, you usually have treatment with a combination of cancer drugs. You might have one of the following: R-CHOP R-CVP bendamustine and rituximab (BR) This is called the induction treatment. After the induction treatment, you might have rituximab (R) alone. This is the maintenance phase. But having more treatment with rituximab doesn’t help everyone with follicular lymphoma. Doctors would like to know who needs to have rituximab after their initial treatment (induction). In this study, they are looking...

 Non-Hodgkin lymphoma /  Wales Wide

Posted 2 years ago by Wales Gene Park

A study looking at pembrolizumab for children and teenagers with a solid tumour or lymphoma This study is looking at a drug called pembrolizumab for children and teenagers who have advanced melanoma or certain other types of solid tumour or lymphoma. This study is for children who are at least 6 months old but haven’t yet reached their 18th birthday. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.

 Haematological Cancer /  London

Posted 2 years ago by Wales Gene Park

A study looking at functional imaging to help diagnose and treat children and young people with solid tumours This study is looking at functional imaging, using a range of scanning techniques to help diagnose, treat and understand more about solid tumours in children and young people. This study is for children and young people up to their 25th birthday at diagnosis.

 Paediatric Cancers /  England

Posted 2 years ago by Wales Gene Park

ATLANTIS: A trial of more treatment after chemotherapy for advanced urinary tract cancer  

 Urological Cancers /  Cardiff

Posted 2 years ago by Wales Gene Park

The aims of this study are to Find out if surgery of the prostate, bladder, penis and kidney causes changes to biomarkers in the body See if there is a link between changes in these biomarkers and complications after surgery See if there is a link between changes in these biomarkers and the cancer coming back

 Urological Cancers /  Wales Wide

Posted 2 years ago by Wales Gene Park

IMPORT: A study looking at improving treatment for children with kidney cancer This study will collect information about children diagnosed with kidney cancer (renal cancer) such as Wilms’ tumour, to help with decisions about treatment in the future.

 Paediatric Cancers /  Cardiff

Posted 2 years ago by Wales Gene Park

FOCUS4: A trial looking at different treatments for different types of bowel cancer Not all bowel cancers are the same and tests can be done on tumour samples from patients with bowel cancer that may help select the best treatment for that individual patient. There are a number of new cancer drugs that may be more beneficial in one type of bowel cancer than another. The FOCUS4 trial programme aims to recruit over 1500 patients at centres across the UK to evaluate how well these new cancer drugs work in different types of bowel cancer. Patients diagnosed with bowel cancer which is not removable by surgery or has spread to elsewhere in their body will be invited to join this programme of trials. Patients who decide to join will be started on a course of chemotherapy (a form of drug treatment aimed to kill the cancer cells) for up to...

 Rare Bowel Cancers /  Cardiff University

Posted 2 years ago by Wales Gene Park

CORGI 2: A study to find genes that might increase or reduce the risk of bowel cancer Colorectal cancer (CRC) remains an important cause of morbidity and mortality. Identifying those at higher risk is important in targeting preventive measures, such as screening colonoscopy, to those most likely to benefit. Much of the risk of CRC and its precursor lesions (mostly polyps) is genetic, but a great deal of the heritability of CRC remains unexplained. Some of the remaining genetic risk probably results from rare genes with large effects, some from uncommon genetic variants with moderate effects and some from common differences with modest or very modest effects. The sub-division between these categories is extremely difficult to predict in advance of successful searches for these genes. The principal aim of this study is to identify additional susceptibility genes for CRC and cancers genetically related to CRC, such as endometrial cancer. This...

 Rare Bowel Cancers /  Birmingham

Posted 2 years ago by Wales Gene Park

ALL-RIC:A trial comparing treatments for acute lymphoblastic leukaemia Doctors are looking for new ways to treat people with acute lymphoblastic leukaemia (ALL) to stop the leukaemia coming back. In this trial, they are comparing a usual treatment with a new combination of treatment. The usual (standard) treatment in this trial is a combination of drugs called FMA. It includes: •fludarabine – a chemotherapy drug •melphalan – a chemotherapy drug •alemtuzumab – a targeted drug The new combination of treatment includes: •cyclophosphamide – a chemotherapy drug •alemtuzumab – a targeted drug •radiotherapy to the whole body (total body irradiation or TBI) Everyone then goes on to have a stem cell transplant with stem cells from another person (an allogeneic stem cell transplant). The chemotherapy and radiotherapy in this trial are low intensity. This is to reduce the possible complications of a transplant. We know from early research that the new combination...

 Chronic lymphocytic leukaemia /  England

Posted 2 years ago by Wales Gene Park

DIAMOND: A study looking at biomarkers in prostate, kidney, bladder and testicular cancer Some people have biomarkers that make them more vulnerable to develop certain types of cancer. In this study, doctors want to look for these biomarkers. They hope this information will help them: •learn more about the causes of cancer •develop better tests and treatments Everyone taking part gives blood, urine, poo and breath samples. Doctors may also ask for a tissue sample if you had, or are going to have, surgery. The main aim of this study is to look for biomarkers that might play a role in prostate, kidney, bladder and testicular cancer. Researchers are also looking for men who are going to have a biopsy to find out whether they have prostate cancer. This is part of a sub study called PRIM. Everyone taking part in the PRIM sub study has a blood test called...

 Prostate Cancer /  Bristol

Posted 2 years ago by Wales Gene Park

This trial is for people whose acute myeloid leukaemia (AML) has come back or continued to grow following their first or second treatment.

 Acute myeloid leukaemia /  Cardiff

Posted 2 years ago by Wales Gene Park

Many cancers have hijacked growth factor receptors and or downstream signalling components through mutations that render the pathway constantly active and so drive cancer cells division. Over the last decade, drugs have been introduced that simultaneously inhibit multiple growth factor pathways (such as tyrosine kinase receptor inhibitors), single pathways (vascular endothelial growth factor receptor, transforming growth factor beta receptor, epidermal growth factor receptor and hedgehog pathway antagonists), mutated targets (B-Raf inhibitors), and downstream signalling targets (MEK inhibitors). While malignancies in patients often demonstrate an initial response to these drugs, cancer recurrence is frequently observed. My group over the last five years has defined cancer stem cells (CaSC) in the two commonest skin cancers, using internationally agreed assays. We have shown in high impact scientific publications that basal cell carcinoma (BCC) CaSC are resistant to both conventional chemotherapy and the recently approved growth factor inhibitor vismodegib. Microarray analysis of treated and...

 Oncology /  Cardiff University

Posted 2 years ago by Wales Gene Park

A trial looking at lenvatinib and pembrolizumab for people with advanced solid tumours (LEAP-005) This trial is for people with one of the following solid tumours : breast cancer whose cells don’t have receptors for the protein Her2 and the hormones oestrogen and progesterone (triple negative breast cancer) ovarian cancer stomach cancer bowel cancer a type of brain tumour called glioblastoma multiforme (GBM) bile duct cancer gallbladder cancer It is for people whose cancer continued to grow or spread to other parts of the body despite treatment (advanced solid tumours). The main aims of this trial are to: find out how well lenvatinib and pembrolizumab work as a treatment for advanced solid tumours learn more about the side effects

 Rare Cancers (non-specific) /  London

Posted 2 years ago by Wales Gene Park

A study looking at improving treatment for children and young people with medulloblastoma (PNET5 MB) The PNET 5 study has been designed for children and young people aged from 3 yrs to 22 yrs with standard risk medulloblastoma who have undergone surgery to remove the primary tumour. The presence of biological markers of the WNT medulloblastoma disease subgroup (mutation of the beta-catenin gene, or presence of the beta-catenin protein and loss of chromosome 6) and aged < 16 defines the patient as Low Risk biological profile. The presence of the WNT markers and aged 16 and over, or the absence of the WNT markers defines the patient as Standard Risk biological profile. Low risk group patients will receive reduced doses of radiotherapy (compared to previous study PNET 4) to the brain and spine every day for 10 days, together with boost doses to the primary tumour for a further 20...

 Classic medulloblastoma /  Cardiff

Posted 2 years ago by Wales Gene Park

Some gliomas have a change (mutation ) in the BRAF gene called BRAF V600. The BRAF gene makes a protein that affects how cancers grow and divide. Dabrafenib and trametinib are targeted drugs. They work by blocking the action of the BRAF protein so possibly stopping the cancer growing or spreading. We know that the combination of dabrafenib and trametinib works for other cancers that have the BRAF V600 change. Researchers think it could help children and young people whose glioma has the BRAF V600 change. In this trial everyone who has a fast growing glioma will have dabrafenib and trametinib. Everyone who has a slow growing glioma will have either: dabrafenib and trametinib or carboplatin and vincristine (standard treatment ) The aims of this trial are to find: how well dabrafenib and trametinib works for children and young people with a glioma how dabrafenib and trametinib works in the...

 Diffuse intrinsic pontine glioma /  London

Posted 2 years ago by Wales Gene Park

Conditions where lymphocytes have become cancerous are called lymphoproliferative disorders and include Chronic lymphocytic leukaemia (CLL) Mantle cell lymphoma Follicular lymphoma Hairy cell leukaemia Splenic lymphoma with villous lymphocytes Doctors want to find out more about these cancerous cells. In this study you will give samples of blood and any extra bone marrow or tissue you may have removed during routine procedures. You will also give a sample of spit (saliva). Researchers will look at both abnormal and normal cells in these samples. They will look for genes, including a particular gene called the ‘immunoglobulin gene’ that help the cancer cell to survive. And, for other gene and chromosome changes that may in future help them predict the outcome of these diseases. The aim of this study is to understand more about how changes to certain genes, proteins and sugars could affect how these diseases develop. This may help develop...

 Classic hairy cell leukemia /  Southampton

Posted 2 years ago by Wales Gene Park

Most tumours that start in the pituitary gland are adenomas which are non cancerous (benign). Some pituitary tumours make extra hormones that can cause symptoms. They are sometimes called neuroendocrine tumours. Very rarely, several members of the same family have a pituitary gland tumour. We know from research that there can be a gene that is abnormal in some of these families. Researchers want to study this and other genes to understand more about how these tumours develop. In this study, they will take blood samples from people who have a pituitary gland tumour, and from other family members. The aim of the study is to identify genes that play a part in the development of pituitary gland tumours. Please note - you won’t get any direct benefit from taking part in this study, nor will it affect any treatment you have. But may it help people in the future.

 Pituitary carcinoma /  London

Posted 2 years ago by Wales Gene Park

 A trial looking at higher doses of chemoradiotherapy for people with locally advanced anal cancer (PLATO ACT5) Anal cancer is rare, but its incidence is rising rapidly. Approximately 1000 cases are diagnosed each year in the UK. Standard treatment usually involves a combination of chemotherapy and radiotherapy (chemoradiotherapy (CRT)). Often the same radiotherapy dose is given regardless of disease stage. Recent improvements in radiotherapy means altered doses can now be given to the tumour whilst sparing normal tissues. PLATO is an integrated protocol, comprising 3 separate trials (ACT3, ACT4 and ACT5) which aims to optimise radiotherapy dose for low-, intermediate- and high-risk disease. ACT5: a seamless randomised pilot, phase II and phase III trial that compares standard-dose CRT (53.2Gy in 28 fractions) with two higher doses of CRT (58.8Gy and 61.6Gy, both in 28 fractions), in patients with locally advanced anal cancer, to see if giving a higher dose of...

 Juvenile Anal Cancer /  Leeds

Posted 2 years ago by Wales Gene Park

Doctors can use surgery to remove: prostate cancer bladder cancer penile cancer kidney cancer Doctors think that one way to monitor patients more closely when they have surgery would be to use biomarkers. A biomarker is a substance in the body that can be measured. In this study, the researchers will look at people’s blood and urine samples before and after surgery to measure certain biomarkers. The aims of this study are to Find out if surgery of the prostate, bladder, penis and kidney causes changes to biomarkers in the body See if there is a link between changes in these biomarkers and complications after surgery See if there is a link between changes in these biomarkers and the cancer coming back You will not directly benefit from taking part in this study. If the researchers find that biomarkers are useful, it could help to improve the care and treatment...

 Penile Cancer /  Wales Wide

Posted 2 years ago by Wales Gene Park

We will undertake a prospective study of adult MAP patients with confirmed bi-allelic mutations across collaborating European centres. Data from upper GI surveillance procedures including endoscopy and histopathology findings will be collated as an ongoing process by the Institute of Medical Genetics, Cardiff, UK where it will entered into a database and stored safely. We will also collect prospectively data on other incident cancers diagnosed in these patients. All causes of death and all dates of death will be recorded. Recruitment of patients from the European centres and consent will be obtained using local procedures, and ethical approval will be obtained in each country. As MAP is a rare disorder, and the interval between surveillance procedures may be as much as 5 years, this study is planned to take place over 20 years.

 MUTYH-Associated Adenomatous Polyposis (MAP) /  Cardiff University

Posted 2 years ago by Wales Gene Park

HumGenDisMolecular pathology of human genetic disease There are many different arms to this study, each one looking at separate conditions. We need to investigate the genes/genetic factors of many individuals/families with exactly the same condition. The cells in your blood carry a complete set of your genetic material (genes), which we can study. We would like to better understand the gene(s)/genetic factors that may be the cause of the condition in you/your family.

 Tumour Disorders

Posted 2 years ago by Wales Gene Park

The PNET 5 study has been designed for children and young people aged from 3 yrs to 22 yrs with standard risk  medulloblastoma who have undergone surgery to remove the primary tumour. The presence of biological markers of  the WNT medulloblastoma disease subgroup (mutation of the beta¬catenin gene, or presence of the beta¬catenin  protein and loss of chromosome 6) and aged  < 16 defines the patient as Low Risk biological profile. The presence of  the WNT markers and aged 16 and over, or the absence of the WNT markers defines the patient as Standard Risk  biological profile. Low risk group patients will receive reduced doses of radiotherapy (compared to previous study PNET 4) to the brain  and spine every day for 10 days, together with boost doses to the primary tumour for a further 20 days. Maintenance chemotherapy will consist of 6 cycles of Regimen A alternating with 6 cycles...

 Medulloblastoma

Posted 2 years ago by Wales Gene Park

PARTNER: Randomised, phase II/III, 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or Gbrca Surgery is often used for early breast cancers. Sometimes you have chemotherapy before surgery. This is called neo adjuvant chemotherapy. It can shrink the cancer and make the surgery more successful. In this trial, researchers are looking at whether adding a drug called olaparib (also called Lynparza) improves neo adjuvant chemotherapy. Olaparib is a type of biological therapy called a PARP-1 inhibitor.  PARP is a protein that helps cells to repair. Doctors think that olaparib can stop the cancer cells from repairing themselves. In this trial, people have 1 of the following: chemotherapy chemotherapy with olaparib The chemotherapy drugs used in this trial are: paclitaxel carboplatin These are commonly used to treat breast cancer but are not routinely used to...

 BRCA1 and BRCA2 /  Wales Wide

Posted 2 years ago by Wales Gene Park

The Genetics of Endocrine Tumours is an observational clinical trial. The study currently has 500 families and 3000 sporadic subjects recruited from almost 50 NHS sites around the country. Any patient with a pituitary tumour is eligible to enrol, though we are particularly interested in the cohort of familial isolated pituitary adenoma (FIPA) patients. FIPA accounts for around 5% of pituitary adenomas with 20% of these patients having a mutation in the gene Aryl Hydrocarbon Receptor Interacting protein (AIP). Our study has helped to characterise AIP and other novel genes that contribute to pituitary tumorigenesis. We are lucky to receive regular bloods and fresh tissue from pituitary tumour patients which are used for DNA/RNA analysis, tissue culture and in-vivo models.

 Genetics /  Cardiff University

Posted 3 years ago by Wales Gene Park

Randomised phase II Trial of olaparib, chemotherapy or olaparib and cediranib in patients with BRCA mutated platinum–resistant ovarian cancer Women with platinum resistant ovarian cancer (OC) have limited responses to standard therapy, and clinical trials with novel agents are therefore highly justified. Olaparib is a potent PARP inhibitor that has shown enhanced activity in women with relapsed BRCA-mutated OC in both platinum sensitive and resistant settings. Angiogenesis inhibitors, such as the oral tyrosine kinase inhibitor cediranib, are active in OC, and have shown additive effects when combined with PARP inhibitors preclinically, as hypoxia-induced downregulation of homologous recombination repair genes, BRCA1, 2 and RAD51 enhances PARP inhibitor sensitivity. Recent phase 2 trials in relapsed platinum-sensitive OC have also shown benefit from the combination of olaparib and cediranib compared to olaparib alone. The OCTOVA trial investigates the benefit of single agent olaparib compared to olaparib and cediranib or weekly paclitaxel in women...

 Familial ovarian cancer /  Velindre Cancer Centre

Posted 3 years ago by Wales Gene Park

ARIEL 4: A Phase 3 Multicenter, Open-label, Randomized Study of Rucaparib versus Chemotherapy in Patients with Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Globally, ovarian cancer is the eighth most common cancer and the seventh leading cause of cancer death among women. Cancer is caused by changes to genes that control the way our cells function. Chemical substances and other formulations are used in treatment. Chemotherapy is a treatment where chemical substances are used to damage and kill cancer cells. An enzyme inhibitor is a molecule that binds to an enzyme, to help slow down a reaction or to prevent unwanted change. Inhibitors are used in cancer treatments for that purpose. Rucaparib is a molecule inhibitor of enzymes. The main purpose of this study is to evaluate safety, disease status and progression-free survival of Rucaparib versus standard chemotherapy for treatment of certain ovarian, fallopian tube and primary...

 Malignant tumor of fallopian tubes /  Velindre Cancer Centre

Posted 3 years ago by Wales Gene Park

We propose to study a group of genetic conditions, called RAS¬MAPK pathway disorders, in which high rates of congenital abnormalities, learning difficulties, short stature and other health and developmental problems occur (including childhood tumours). The incidence of these various problems is not yet fully known in the different conditions. This study seeks to find out how common these different features are across the conditions. Changes in many different genes cause these disorders. The proteins that these genes code for all work together in a biochemical pathway, called the RAS¬MAPK pathway. We will examine what particular problems are associated with particular changes (mutations) in each of the genes. Some patients with these conditions do not currently have a known genetic reason for their condition, and we shall seek to identify new genes for these conditions. To do this, a group of patients will be studied, and blood and, where available, other...

 RAS-MAPK pathway /  Cardiff University

Posted 3 years ago by Wales Gene Park

Challenge: A Phase III Study Of The Impact Of A Physical Activity Program On Disease-Free Survival In Patients With High Risk Stage II Or Stage III Colon Cancer: A Randomised Controlled Trial CHALLENGE aims to determine whether a supervised physical activity (PA) programme in patients with high risk Stage II or Stage III colon cancer will improve 3- year disease-free survival (DFS) in comparison to standard care. The impact on patient-reported outcome measures (PROMS) and quality of life will also be assessed. There is compelling observational data that PA is associated with colon cancer incidence, recurrence, survival, and quality of life. The trial arms are: Intervention: A 36 month structured physical activity programme comprising supervised physical activity sessions and behaviour support sessions and provision of general health education materials (on diet and exercise). Standard Care: Provision of general health education materials on diet and exercise only.

 Rare Non-specific /  Velindre Cancer Centre

Posted 3 years ago by Wales Gene Park

Relapse (the chance of disease coming back after treatment) is very high in acute myeloid leukaemia even after  curative approaches with intensive chemotherapy and bone marrow transplantation. The bone marrow  microenvironment which includes the stromal cells (MSC) surrounding the blood cells/leukaemia cells is thought to  be a key player in chemotherapy resistance and acts as a sanctuary site for minimal residual disease (MRD) from  which relapse may occur. Once MRD is detectable, frank relapse is likely within a short time-frame affording  insufficient time for effective salvage interventions. In addition, a large proportion of patients there is no informative  MRD marker thus disease relapse can occur with little warning. In this study, we aim to investigate the role of patient  MSC in protecting AML cells at different stages of treatment including post chemotherapy and after stem cell  transplantation. By developing a 3D dynamic model of leukaemia-stroma interactions which can better mimic...

 Acute myeloid leukaemia /  Cardiff University

Posted 3 years ago by Wales Gene Park

Researchers want to know more about people who have mesothelioma, their symptoms and how it affects their life. Mesothelioma of the lung is difficult to treat. Researchers are looking for better treatments and how to improve care for people with mesothelioma. In this study they will collect information about: your quality of life any symptoms you have They will also collect medical information including: blood samples any tests you might have Mesothelioma can cause fluid to build up between the sheets of tissue that surround your lung. Treatment for this is to drain the fluid off. The researchers also want to collect samples of this fluid. The team will use this information to: find out more about mesothelioma improve the care for people with mesothelioma

 mesothelioma /  Wales Wide

Posted 3 years ago by Wales Gene Park

The role of routine and novel biomarkers and their correlation with clinical outcome measures in patients undergoing surgical interventions for benign and malignant disorders of the prostate and bladder.

 Penile Cancer /  Wrexham

Posted 3 years ago by Wales Gene Park

EMBRACE: Epidemiological study of BRCA1 and BRCA2 mutation carriers This study collects information about people who have inherited faulty breast cancer genes. A small number of men and women have inherited faulty genes which means that they at an increased risk of developing certain cancers. Two of these genes are called BRCA1 and BRCA2. When someone has a fault in these genes they are more likely to develop cancers of the breast, ovary or prostate. The EMBRACE study, which stands for Epidemiological Study of Familial Breast Cancer, aims to create a register of families who have a fault in these genes. The people taking part will be asked to fill in a questionnaire and to give a small sample of blood, which will be looked at in a laboratory. With this information they hope to find out How many people go on to develop cancer What other factors may play a part...

 BRCA1 and BRCA2 /  Cardiff


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