Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma — BriTROC-2  

Ovarian Cancer Clinical Trial

Official title: Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Carcinoma
• Carcinosarcoma
• Carcinosarcoma, Ovarian
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• High Grade Serous Carcinoma
• Mixed Tumor, Mullerian
• Ovarian Cancer
• Primary Peritoneal Carcinoma

• NCT number: NCT05537844
• Study type: Observational
• Source: Cancer Research UK, Glasgow
• Contact: Liz-Anne Lewsley
• Phone: 01413017193
• Email: liz-anne.lewsley@glasgow.ac.uk
• Status: Recruiting
• Start date: October 27, 2021
• Completion date: April 27, 2025