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

Last updated: September 21, 2022
Sponsor: Liz-Anne Lewsley
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fallopian Tube Cancer

Ovarian Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT05537844
BriTROC2-2019
  • Ages > 16
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 16 years.
  2. Ability to provide written informed consent prior to participating in the trial andany 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 anyhistological subtype in patients with known germline mutations in BRCA1 or BRCA2.
  5. Willingness to comply with scheduled visits, treatment plans, laboratory tests andother 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 ofhigh-grade serous, high-grade (grade 3) endometrioid or carcinosarcoma histologies whohave 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 discussionwith the trials team.

Exclusion

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 mutationin 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 significantdisorder or lab finding that makes it undesirable for the patient to participate inthe trial
  7. History of physical or psychiatric disorder that would prevent informed consent andcompliance with protocol
  8. Pregnant or lactating women
  9. Patients with any other severe concurrent disease which may increase the riskassociated with trial participation
  10. Any psychological, familial, sociological or geographical consideration potentiallyhampering compliance with the trial protocol and follow up schedule.

Study Design

Total Participants: 250
Study Start date:
October 27, 2021
Estimated Completion Date:
April 27, 2025

Study 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.

Connect with a study center

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital NHS Trust

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • University College London Hospital

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • St Mary's Hospital

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • The Christie Hospital NHS Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

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