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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
Sponsor:
Collaborator:
Ovarian Cancer Action
Information provided by (Responsible Party):
Liz-Anne Lewsley, Cancer Research UK, Glasgow

Study Description
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Brief 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.


Condition or disease
Ovarian Cancer High Grade Serous Carcinoma Carcinosarcoma, Ovarian Fallopian Tube Cancer Primary Peritoneal Carcinoma BRCA1 Mutation BRCA2 Mutation

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Whole Blood Samples for germline DNA isolation [ Time Frame: Baseline ]
    To obtain whole blood for germline DNA isolation.

  2. 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.

  3. 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
  1. Tumour tissue from diagnosis from 250 patients
  2. Whole blood samples from 250 patients
  3. Plasma blood samples from 250 patients
  4. Serum blood samples from 250 patients
  5. Ascites/pleural fluid/peritoneal washings

Eligibility Criteria
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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
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Liz-Anne Lewsley 01413017193 liz-anne.lewsley@glasgow.ac.uk
Contact: Debbie Rai 01413017946 debbie.rai@glasgow.ac.uk

Locations
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United Kingdom
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       a.petrie@ed.ac.uk   
Principal Investigator: Charlie Gourley         
The Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Lauren McNamara       lauren.mcnamara@ggc.scot.nhs.uk   
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         
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Eleanor Holmes       eleanor.holmes7@nhs.net   
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         
Sponsors and Collaborators
Liz-Anne Lewsley
Ovarian Cancer Action
Investigators
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Principal Investigator: Iain McNeish Imperial College London
More Information
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Responsible Party: Liz-Anne Lewsley, Project Manager, Cancer Research UK, Glasgow
ClinicalTrials.gov Identifier: NCT05537844    
Other Study ID Numbers: BriTROC2-2019
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Fallopian Tube Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Fallopian Tube Diseases
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Cystadenocarcinoma
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous