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

N/A
Recruiting
Led By Iain McNeish
Research Sponsored by Liz-Anne Lewsley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Ovarian Cancer
  • Serous Carcinoma
  • Ovarian Carcinosarcoma
  • Peritoneal Carcinoma
  • BRCA1
  • BRCA2 Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumour Biopsies (to be collected from 250 patients)
Secondary study objectives
Ascites/Peritoneal Washings (where possible from diagnosis and relapse)
Plasma Blood Samples (to be collected for storage for future analyses)
Whole Blood Samples for germline DNA isolation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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Who is running the clinical trial?

Liz-Anne LewsleyLead Sponsor
2 Previous Clinical Trials
1,048 Total Patients Enrolled
Ovarian Cancer ActionUNKNOWN
Iain McNeishPrincipal InvestigatorImperial College London
1 Previous Clinical Trials
107 Total Patients Enrolled
~60 spots leftby Jan 2026
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