Official Title
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Brief Title
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Protocol ID
NCT05537844
Lead Sponsor
Liz-Anne Lewsley
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 Period
-
Enrollment Count
250 participants
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.
Filters
Ovarian Cancer
High Grade Serous Carcinoma
Carcinosarcoma, Ovarian
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
BRCA1 Mutation
BRCA2 Mutation
UNKNOWN
CHILD
ADULT
OLDER_ADULT