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

NCT05537844 | Unknown

• 1 other identifier: BriTROC2-2019
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 11

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.

Conditions

Ovarian Cancer; High Grade Serous Carcinoma; Carcinosarcoma, Ovarian; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; BRCA1 Mutation; BRCA2 Mutation

Outcome Measures

Primary Outcomes (1)

• Tumour Biopsies (to be collected from 250 patients)

  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 Outcomes (3)

• Whole Blood Samples for germline DNA isolation

  Baseline

• Plasma Blood Samples (to be collected for storage for future analyses)

  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)

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Female patients with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 16 years.
• Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed.
• Ovarian, fallopian tube or primary peritoneal carcinoma of high-grade serous, high-grade (grade 3) endometrioid or carcinosarcoma histologies.
• Patients with ovarian, fallopian tube or primary peritoneal carcinoma of any histological subtype in patients with known germline mutations in BRCA1 or BRCA2.
• Willingness to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
• Life expectancy \> 6 months.
• No contraindication to obtaining a surgical or image-guided biopsy.
• 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.

You may not qualify if:

• 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
• Borderline/low malignant potential tumours
• Any non-epithelial ovarian malignancy
• Diagnosis of high-grade serous cancer made on cytology only
• Patients who have received any prior treatment for known high-grade ovarian carcinoma
• 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
• History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
• Pregnant or lactating women
• Patients with any other severe concurrent disease which may increase the risk associated with trial participation
• Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.

Sponsors & Collaborators

• Liz-Anne Lewsley: lead
• Ovarian Cancer Action: collaborator

Study Sites (11)

Bristol Haematology & Oncology Centre

Bristol, BS2 8ED, United Kingdom

NOT YET RECRUITING

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

University College London Hospital

London, NW1 2BU, United Kingdom

NOT YET RECRUITING

Royal Marsden Hospital NHS Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

St Mary's Hospital

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

The Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

NOT YET RECRUITING

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

NOT YET RECRUITING

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

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinosarcoma; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Fallopian Tube Diseases

Study Officials

• Iain McNeish

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz-Anne Lewsley

CONTACT

01413017193; liz-anne.lewsley@glasgow.ac.uk

Debbie Rai

CONTACT

01413017946; debbie.rai@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 13, 2022
• Study Start: October 27, 2021
• Primary Completion: October 27, 2024
• Study Completion: April 27, 2025
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

GB (11)