Ovarian CancerBriTROC-2NCT05537844
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
An observational study of Ovarian Cancer and High Grade Serous Carcinoma, run by Liz-Anne Lewsley at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Ovarian Cancer, High Grade Serous Carcinoma, Carcinosarcoma, Ovarian
- How many people
- 250 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 27 Oct 2021to 27 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites, 11 recruiting
- Not yet recruiting
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED
Axel Walther
- Not yet recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
James Brenton
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
Anne Petrie, a.petrie@ed.ac.uk
Charlie Gourley
- Not yet recruiting
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Lauren McNamara, lauren.mcnamara@ggc.scot.nhs.uk
Ros Glasspool
- Recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Rowan Miller
- Not yet recruiting
University College London Hospital
London, NW1 2BU
Michelle Lockley
- Recruiting
Royal Marsden Hospital NHS Trust
London, SW3 6JJ
Jeremy Tai, Jeremy.Tai@rmh.nhs.uk
Susana Banerjee
- Recruiting
Hammersmith Hospital
London, W12 0HS
Eleanor Holmes, eleanor.holmes7@nhs.net
Laura TOOKMAN
- Not yet recruiting
St Mary's Hospital
Manchester, M13 9WL
Richard Edmondson
- Not yet recruiting
The Christie Hospital NHS Trust
Manchester, M20 4BX
Andrew Clamp
- Not yet recruiting
Mount Vernon Cancer Centre
Northwood, HA6 2RN
Marcia Hall
About this study
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.
Read the 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.
- Conditions
- Ovarian Cancer, High Grade Serous Carcinoma, Carcinosarcoma, Ovarian, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, BRCA1 Mutation
- Medical subject headings
- Ovarian Neoplasms, Carcinosarcoma, Fallopian Tube Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Whole Blood Samples for germline DNA isolation
To obtain whole blood for germline DNA isolation.
Measured: Baseline
Plasma Blood Samples (to be collected for storage for future analyses)
To obtain plasma for ctDNA at diagnosis, during first line chemotherapy, at follow up and at the time of relapse.
Measured: 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)
To obtain ascites/washings from women at diagnosis and at the time of relapse.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start27 Oct 2021
- Primary completion27 Oct 2024 (estimated)
- Study completion27 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liz-Anne Lewsley
- Sponsor type
- University, hospital or other
- Collaborators
- Ovarian Cancer Action
- Responsible party
- Sponsor-investigator, Liz-Anne Lewsley, Cancer Research UK, Glasgow
- Investigators
- Iain McNeish, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537844
- Sponsor's protocol ID
- BriTROC2-2019
- Acronym
- BriTROC-2
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
- ClinicalTrials.gov ID
- NCT05537844
- Acronym / sponsor ID
- BriTROC-2 / BriTROC2-2019
- Conditions
- Ovarian Cancer, High Grade Serous Carcinoma, Carcinosarcoma, Ovarian, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, BRCA1 Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Liz-Anne LewsleyUniversity, hospital or other
- Collaborators
- Ovarian Cancer Action
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 27 Oct 2024 (estimated)
- Study completion
- 27 Apr 2025 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Whole Blood Samples for germline DNA isolation
Time frame: Baseline
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
Ascites/Peritoneal Washings (where possible from diagnosis and relapse)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain McNeish principal investigator
Imperial College London
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and High Grade Serous Carcinoma, run by Liz-Anne Lewsley at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liz-Anne Lewsley (01413017193, liz-anne.lewsley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour Biopsies (to be collected from 250 patients) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.