Trial Title:
Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
NCT ID:
NCT05537844
Condition:
Ovarian Cancer
High Grade Serous Carcinoma
Carcinosarcoma, Ovarian
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
BRCA1 Mutation
BRCA2 Mutation
Conditions: Official terms:
Carcinoma
Fallopian Tube Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Cystadenocarcinoma, Serous
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Gender description:
Female patients with ovarian cancer
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bristol Haematology & Oncology Centre
Address:
City:
Bristol
Zip:
BS2 8ED
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Axel Walther
Email:
Principal Investigator
Facility:
Name:
Addenbrookes Hospital
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
James Brenton
Email:
Principal Investigator
Facility:
Name:
Western General Hospital
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Anne Petrie
Email:
a.petrie@ed.ac.uk
Investigator:
Last name:
Charlie Gourley
Email:
Principal Investigator
Facility:
Name:
The Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Lauren McNamara
Email:
lauren.mcnamara@ggc.scot.nhs.uk
Investigator:
Last name:
Ros Glasspool
Email:
Principal Investigator
Investigator:
Last name:
Patricia Roxburgh
Email:
Sub-Investigator
Facility:
Name:
St Bartholomew's Hospital
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Rowan Miller
Email:
Principal Investigator
Facility:
Name:
University College London Hospital
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Michelle Lockley
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital NHS Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jeremy Tai
Email:
Jeremy.Tai@rmh.nhs.uk
Investigator:
Last name:
Susana Banerjee
Email:
Principal Investigator
Facility:
Name:
Hammersmith Hospital
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Eleanor Holmes
Email:
eleanor.holmes7@nhs.net
Investigator:
Last name:
Laura TOOKMAN
Email:
Principal Investigator
Facility:
Name:
St Mary's Hospital
Address:
City:
Manchester
Zip:
M13 9WL
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Richard Edmondson
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital NHS Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Andrew Clamp
Email:
Principal Investigator
Facility:
Name:
Mount Vernon Cancer Centre
Address:
City:
Northwood
Zip:
HA6 2RN
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Marcia Hall
Email:
Principal Investigator
Start date:
October 27, 2021
Completion date:
April 27, 2025
Lead sponsor:
Agency:
Liz-Anne Lewsley
Agency class:
Other
Collaborator:
Agency:
Ovarian Cancer Action
Agency class:
Other
Source:
Cancer Research UK, Glasgow
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05537844
