Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma (BriTROC-2)
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|ClinicalTrials.gov Identifier: NCT05537844|
Recruitment Status : Recruiting
First Posted : September 13, 2022
Last Update Posted : September 23, 2022
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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.
|Condition or disease|
|Ovarian Cancer High Grade Serous Carcinoma Carcinosarcoma, Ovarian Fallopian Tube Cancer Primary Peritoneal Carcinoma BRCA1 Mutation BRCA2 Mutation|
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|
|Estimated Enrollment :||250 participants|
|Official Title:||Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma|
|Actual Study Start Date :||October 27, 2021|
|Estimated Primary Completion Date :||October 27, 2024|
|Estimated Study Completion Date :||April 27, 2025|
- Tumour Biopsies (to be collected from 250 patients) [ Time Frame: Through study completion, an average of 1 year ]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.
- Whole Blood Samples for germline DNA isolation [ Time Frame: Baseline ]To obtain whole blood for germline DNA isolation.
- Plasma Blood Samples (to be collected for storage for future analyses) [ Time Frame: Baseline and prior to Cycles 1-3 of chemotherapy (depending on treatment this could be up to 28 days), relapse ]To obtain plasma for ctDNA at diagnosis, during first line chemotherapy, at follow up and at the time of relapse.
- Ascites/Peritoneal Washings (where possible from diagnosis and relapse) [ Time Frame: Through study completion, an average of 1 year ]To obtain ascites/washings from women at diagnosis and at the time of relapse.
Biospecimen Retention: Samples With DNA
- Tumour tissue from diagnosis from 250 patients
- Whole blood samples from 250 patients
- Plasma blood samples from 250 patients
- Serum blood samples from 250 patients
- Ascites/pleural fluid/peritoneal washings
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female patients with ovarian cancer|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Age ≥ 16 years.
- Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed.
- Ovarian, fallopian tube or primary peritoneal carcinoma of high-grade serous, high-grade (grade 3) endometrioid or carcinosarcoma histologies.
- Patients with ovarian, fallopian tube or primary peritoneal carcinoma of any histological subtype in patients with known germline mutations in BRCA1 or BRCA2.
- Willingness to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
- Life expectancy > 6 months.
- No contraindication to obtaining a surgical or image-guided biopsy.
- Patients with confirmed ovarian, fallopian tube or primary peritoneal carcinoma of high-grade serous, high-grade (grade 3) endometrioid or carcinosarcoma histologies who have consented for their tissue to be collected under a generic tissue consent (i.e. have not consented to Part 1) may be eligible for full consent following discussion with the trials team.
- Ovarian, primary peritoneal or fallopian tube cancer of low grade serous, grades 1 or 2 endometrioid or clear cell subtypes unless associated with known germline mutation in BRCA1 or BRCA2
- Borderline/low malignant potential tumours
- Any non-epithelial ovarian malignancy
- Diagnosis of high-grade serous cancer made on cytology only
- Patients who have received any prior treatment for known high-grade ovarian carcinoma
- Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the trial
- History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
- Pregnant or lactating women
- Patients with any other severe concurrent disease which may increase the risk associated with trial participation
- Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05537844
|Contact: Liz-Anne Lewsleyfirstname.lastname@example.org|
|Contact: Debbie Raiemail@example.com|
|Bristol Haematology & Oncology Centre||Not yet recruiting|
|Bristol, United Kingdom, BS2 8ED|
|Principal Investigator: Axel Walther|
|Addenbrookes Hospital||Not yet recruiting|
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator: James Brenton|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Anne Petrie firstname.lastname@example.org|
|Principal Investigator: Charlie Gourley|
|The Beatson West of Scotland Cancer Centre||Not yet recruiting|
|Glasgow, United Kingdom, G12 0YN|
|Contact: Lauren McNamara email@example.com|
|Principal Investigator: Ros Glasspool|
|Sub-Investigator: Patricia Roxburgh|
|St Bartholomew's Hospital||Recruiting|
|London, United Kingdom, EC1A 7BE|
|Principal Investigator: Rowan Miller|
|University College London Hospital||Not yet recruiting|
|London, United Kingdom, NW1 2BU|
|Principal Investigator: Michelle Lockley|
|Royal Marsden Hospital NHS Trust||Recruiting|
|London, United Kingdom, SW3 6JJ|
|Contact: Jeremy Tai Jeremy.Tai@rmh.nhs.uk|
|Principal Investigator: Susana Banerjee|
|London, United Kingdom, W12 0HS|
|Contact: Eleanor Holmes firstname.lastname@example.org|
|Principal Investigator: Laura TOOKMAN|
|St Mary's Hospital||Not yet recruiting|
|Manchester, United Kingdom, M13 9WL|
|Principal Investigator: Richard Edmondson|
|The Christie Hospital NHS Trust||Not yet recruiting|
|Manchester, United Kingdom, M20 4BX|
|Principal Investigator: Andrew Clamp|
|Mount Vernon Cancer Centre||Not yet recruiting|
|Northwood, United Kingdom, HA6 2RN|
|Principal Investigator: Marcia Hall|
|Principal Investigator:||Iain McNeish||Imperial College London|
|Responsible Party:||Liz-Anne Lewsley, Project Manager, Cancer Research UK, Glasgow|
|Other Study ID Numbers:||
|First Posted:||September 13, 2022 Key Record Dates|
|Last Update Posted:||September 23, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Fallopian Tube Neoplasms
Mixed Tumor, Mullerian
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Genital Neoplasms, Female
Fallopian Tube Diseases
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Neoplasms, Cystic, Mucinous, and Serous