Ovarian Cancer Clinical Trial
— BriTROC-2Official title:
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | April 27, 2025 |
Est. primary completion date | October 27, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 16 years. 2. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed. 3. Ovarian, fallopian tube or primary peritoneal carcinoma of high-grade serous, high-grade (grade 3) endometrioid or carcinosarcoma histologies. 4. Patients with ovarian, fallopian tube or primary peritoneal carcinoma of any histological subtype in patients with known germline mutations in BRCA1 or BRCA2. 5. Willingness to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures. 6. Life expectancy > 6 months. 7. No contraindication to obtaining a surgical or image-guided biopsy. 8. 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. Exclusion Criteria: 1. 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 2. Borderline/low malignant potential tumours 3. Any non-epithelial ovarian malignancy 4. Diagnosis of high-grade serous cancer made on cytology only 5. Patients who have received any prior treatment for known high-grade ovarian carcinoma 6. 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 7. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol 8. Pregnant or lactating women 9. Patients with any other severe concurrent disease which may increase the risk associated with trial participation 10. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bristol Haematology & Oncology Centre | Bristol | |
United Kingdom | Addenbrookes Hospital | Cambridge | |
United Kingdom | Western General Hospital | Edinburgh | |
United Kingdom | The Beatson West of Scotland Cancer Centre | Glasgow | |
United Kingdom | Hammersmith Hospital | London | |
United Kingdom | Royal Marsden Hospital NHS Trust | London | |
United Kingdom | St Bartholomew's Hospital | London | |
United Kingdom | University College London Hospital | London | |
United Kingdom | St Mary's Hospital | Manchester | |
United Kingdom | The Christie Hospital NHS Trust | Manchester | |
United Kingdom | Mount Vernon Cancer Centre | Northwood |
Lead Sponsor | Collaborator |
---|---|
Liz-Anne Lewsley | Ovarian Cancer Action |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an average of 1 year | |
Secondary | Whole Blood Samples for germline DNA isolation | To obtain whole blood for germline DNA isolation. | Baseline | |
Secondary | 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. | Baseline and prior to Cycles 1-3 of chemotherapy (depending on treatment this could be up to 28 days), relapse | |
Secondary | Ascites/Peritoneal Washings (where possible from diagnosis and relapse) | To obtain ascites/washings from women at diagnosis and at the time of relapse. | Through study completion, an average of 1 year |
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