In BriTROC-2, up to 250 women with a confirmed diagnosis of high-grade serous/high-grade endometrioid or carcinosarcoma will be eligible for full consent (Part 2) and registration to BriTROC-2 and will be followed prospectively until first relapse. Women with presumed newly-diagnosed high-grade serous carcinoma of the ovary, fallopian tube or peritoneum can be approached for consent to Part 1 (screening consent) of BriTROC-2 prior to formal diagnosis. The aim of this study is to acquire tumour material at diagnosis and relapse, whole blood for genomic analysis and plasma for ctDNA. This study will also isolate single cells and establish organoid cultures from ascites/peritoneal washings.
BriTROC-2 is a sample collection study from women with ovarian cancer from the point of diagnosis to the time of disease relapse. Ovarian cancer has a poor prognosis. The large majority of patients with ovarian cancer will relapse and ultimately develop fatal chemotherapy resistance. Although there is a wealth of information regarding the molecular basis of ovarian cancer at diagnosis, very little is known about the drivers of treatment resistance (both intrinsic and acquired) and the processes that are active at relapse. This research requires sequential collection of tumour material for women throughout the course of their disease. This multicentre study will collect tumour samples, ascites (fluid within the abdomen) and blood from women with newly diagnosed ovarian cancer and follow these women through to relapse of their disease. The samples collected will be used to look at patterns within the tumour to identify those that are able to predict response to chemotherapy and outcome. Assays and models will be developed that can look at the process that are active in a tumour at time of sample acquisition. This will give clues into the mechanisms that drive treatment resistance. Ultimately this research aims to guide future treatment options for women with ovarian cancer. Recruitment will be over 3 years and this study will be conducted at sites with expertise in managing ovarian cancer and the ability to carry out the appropriate sample collection and collect high quality clinical data. This study is the second collaborative project within the UK to collect samples from women with ovarian cancer. The success of the first study, BriTROC-1, demonstrated the feasibility of sample collection from women with relapsed ovarian cancer. The methods and frameworks established in BriTROC-1 will be used for BriTROC-2.
Study Type
OBSERVATIONAL
Enrollment
250
Bristol Haematology & Oncology Centre
Bristol, United Kingdom
NOT_YET_RECRUITINGAddenbrookes Hospital
Cambridge, United Kingdom
NOT_YET_RECRUITINGWestern General Hospital
Edinburgh, United Kingdom
RECRUITINGThe Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
NOT_YET_RECRUITINGSt Bartholomew's Hospital
London, United Kingdom
RECRUITINGUniversity College London Hospital
London, United Kingdom
NOT_YET_RECRUITINGRoyal Marsden Hospital NHS Trust
London, United Kingdom
RECRUITINGHammersmith Hospital
London, United Kingdom
RECRUITINGSt Mary's Hospital
Manchester, United Kingdom
NOT_YET_RECRUITINGThe Christie Hospital NHS Trust
Manchester, United Kingdom
NOT_YET_RECRUITING...and 1 more locations
Tumour Biopsies (to be collected from 250 patients)
To obtain tumour biopsies from 250 women with newly diagnosed high-grade carcinoma of the ovary, fallopian tube or peritoneum - all those with high-grade serous carcinoma (HGSC), high-grade endometrioid carcinoma or carcinosarcoma will be eligible.
Time frame: Through study completion, an average of 1 year
Whole Blood Samples for germline DNA isolation
To obtain whole blood for germline DNA isolation.
Time frame: Baseline
Plasma Blood Samples (to be collected for storage for future analyses)
To obtain plasma for ctDNA at diagnosis, during first line chemotherapy, at follow up and at the time of relapse.
Time frame: Baseline and prior to Cycles 1-3 of chemotherapy (depending on treatment this could be up to 28 days), relapse
Ascites/Peritoneal Washings (where possible from diagnosis and relapse)
To obtain ascites/washings from women at diagnosis and at the time of relapse.
Time frame: Through study completion, an average of 1 year
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