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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

Tracking Information
First Submitted Date September 5, 2022
First Posted Date September 13, 2022
Last Update Posted Date September 23, 2022
Actual Study Start Date October 27, 2021
Estimated Primary Completion Date October 27, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2022)		 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.
Original Primary Outcome Measures
 (submitted: September 8, 2022)		 Tumour Biopsies [ 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.
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2022)
  • Whole Blood Samples for germline DNA isolation [ Time Frame: Baseline ]
    To obtain whole blood for germline DNA isolation.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: September 8, 2022)
  • Whole Blood Samples [ Time Frame: Baseline ]
    To obtain whole blood for germline DNA isolation.
  • Plasma Blood Samples [ 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.
  • Ascites/Peritoneal Washings [ Time Frame: Through study completion, an average of 1 year ]
    To obtain ascites/washings from women at diagnosis and at the time of relapse.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Official Title Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  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
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.
Condition
  • Ovarian Cancer
  • High Grade Serous Carcinoma
  • Carcinosarcoma, Ovarian
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • BRCA1 Mutation
  • BRCA2 Mutation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 8, 2022)		 250
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 27, 2025
Estimated Primary Completion Date October 27, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female patients with ovarian cancer
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Liz-Anne Lewsley 01413017193 liz-anne.lewsley@glasgow.ac.uk
Contact: Debbie Rai 01413017946 debbie.rai@glasgow.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT05537844
Other Study ID Numbers BriTROC2-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Liz-Anne Lewsley, Cancer Research UK, Glasgow
Original Responsible Party Same as current
Current Study Sponsor Liz-Anne Lewsley
Original Study Sponsor Same as current
Collaborators Ovarian Cancer Action
Investigators
Principal Investigator: Iain McNeish Imperial College London
PRS Account Cancer Research UK, Glasgow
Verification Date September 2022