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

September 21, 2022 updated by: Liz-Anne Lewsley

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Not yet recruiting
        • Bristol Haematology & Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • Addenbrookes Hospital
        • Principal Investigator:
          • James Brenton
      • Edinburgh, United Kingdom, EH4 2XU
      • Glasgow, United Kingdom, G12 0YN
        • Not yet recruiting
        • The Beatson West of Scotland Cancer Centre
        • Sub-Investigator:
          • Patricia Roxburgh
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Principal Investigator:
          • Rowan Miller
      • London, United Kingdom, W12 0HS
      • London, United Kingdom, NW1 2BU
        • Not yet recruiting
        • University College London Hospital
      • London, United Kingdom, SW3 6JJ
      • Manchester, United Kingdom, M13 9WL
        • Not yet recruiting
        • St Mary's Hospital
        • Principal Investigator:
          • Richard Edmondson
      • Manchester, United Kingdom, M20 4BX
        • Not yet recruiting
        • The Christie Hospital NHS Trust
      • Northwood, United Kingdom, HA6 2RN
        • Not yet recruiting
        • Mount Vernon Cancer Centre
        • Principal Investigator:
          • Marcia Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

In BriTROC-2, a cohort of women with presumed newly-diagnosed high-grade carcinoma of the ovary, fallopian tube or peritoneum will be recruited at the time of diagnosis and approached for consent to Part 1 (screening consent) of 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. 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Blood Samples for germline DNA isolation
Time Frame: Baseline
To obtain whole blood for germline DNA isolation.
Baseline
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.
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)
Time Frame: Through study completion, an average of 1 year
To obtain ascites/washings from women at diagnosis and at the time of relapse.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liz-Anne Lewsley

Collaborators

Ovarian Cancer Action

Investigators

  • Principal Investigator: Iain McNeish, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2021

Primary Completion (ANTICIPATED)

October 27, 2024

Study Completion (ANTICIPATED)

April 27, 2025

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (ACTUAL)

September 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BriTROC2-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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