Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
NCT ID: NCT05537844
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
250 participants
OBSERVATIONAL
2021-10-27
2025-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
NCT06588322
Impact of Different BRCA1/2 Gene Variants on Response to Therapy and Prognosis of Ovarian Cancer
NCT06775470
Genomic BRCA and Extensive ovArian Cancer Testing
NCT04027868
Prospective Identification and Validation of "BRCANess" Profile in Ovarian Epithelial Cancer
NCT02524808
Ribociclib and Letrozole Treatment in Ovarian Cancer
NCT03673124
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
16 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ovarian Cancer Action
UNKNOWN
Liz-Anne Lewsley
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Liz-Anne Lewsley
Project Manager
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iain McNeish
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Royal Marsden Hospital NHS Trust
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
St Mary's Hospital
Manchester, , United Kingdom
The Christie Hospital NHS Trust
Manchester, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BriTROC2-2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.