BriTROC1 (The UK Translational Research in Ovarian Cancer Collaborative) - Sample collection study in recurrent high grade serous ovarian cancer (HGSOC)
| ISRCTN | ISRCTN09180474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09180474 |
| Secondary identifying numbers | 13727 |
- Submission date
- 03/04/2013
- Registration date
- 27/08/2013
- Last edited
- 24/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Liz-Anne Lewsley
Scientific
Scientific
Beatson Oncology Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 141 301 7193 |
|---|---|
| Liz-Anne.Lewsley@glasgow.ac.uk |
Study information
| Study design | Multi-centre centre non-randomised sample collection observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Patient information sheet is available on the Cancer Research UK Clinical Trials Unit website: http://www.cactusonline.org.uk/rep/open_in_house_trials_yd7r63sh.pdf |
| Scientific title | BriTROC1: Sample collection study to investigate the role of Homologous Recombination Deficiency in platinum sensitivity in recurrent high grade serous ovarian cancer |
| Study acronym | BriTROC1 |
| Study objectives | The prevalence of patients with pre-existing Homologous Recombination Deficiency (HRD), including germline and somatic BRCA1 and BRCA2 mutation and epigenetic silencing, will be higher in platinum-sensitive relapsed populations than in platinum-resistant patients. Taken together with mutation analysis of other HRD genes, the overall proportion of HRD in platinum-sensitive relapsed high grade serous ovarian cancer (HGSOC) may be 50-60%. Examination of HRD biomarkers in biopsy tissue at the time of relapse, together with comparison with original tissue and germline DNA, will identify markers of platinum response as well as novel mechanisms of resistance. |
| Ethics approval(s) | NRES Committee East of England - Cambridge Central, 23/08/2012, ref: 12/EE/0349 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube |
| Intervention | Imaging guided (Ultrasound or CT), intra-operative or other suitable biopsies will be taken for research purposes from women who meet the eligibility criteria and who have been given written, informed consent. Blood will also be taken for storage of plasma and extraction of genomic DNA. Ascites will be collected if present and if drainage is deemed clinically indicated. For patients who consent, a further biopsy at subsequent relapse of disease will be taken. Patients will not be followed up within the context of this study. |
| Intervention type | Other |
| Primary outcome measure | To obtain 300 fit-for purpose tumour biopsies from women with relapsed high grade serous ovarian cancer. Patients will have biopsy at baseline. This will take place at baseline after consent. |
| Secondary outcome measures | 1. Assessment of mutations in HRD genes, BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, in relapsed HGSOC samples by targeted sequencing 2. Comparison of allelic ratio of BRCA1 and BRCA2 in relapsed HGSOC and archival tumour samples taken at the time of diagnosis 3. Analysis of mutations in TP53 (positive control for high grade serous pathology), PTEN, APC, BRAF, KRAS, PIK3CA in relapsed HGSOC and archival tumour samples 4. Assessment of germline DNA mutations in BRCA1, BRCA2, RAD51C, RAD51D, BRIP1 in women with relapsed HGSOC 5. Assessment of methylation of BRCA1 and BRCA2 in relapsed HGSOC and archival tumour samples taken at the time of diagnosis Timepoints: Baseline blood samples and pre chemotherapy (cycles 1 and 2, optional), archival tumour samples from original surgery. |
| Overall study start date | 11/12/2012 |
| Completion date | 30/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | UK Sample Size: 300 |
| Key inclusion criteria | 1. Patients with recurrent histologically-proven high grade serous ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer. 2. Patients may have received no more than two lines of prior chemotherapy 3. Availability of formalin-fixed, paraffin-embedded tissue taken at the time of original diagnosis of high grade serous ovarian cancer. This may be primary surgical debulking specimen OR core biopsy. For those with only a core biopsy from time of diagnosis, availability of specimen taken at interval debulking surgery is desirable, but not essential. 4. Patients must have disease deemed suitable for imaging-guided biopsy (ultrasound or CT) by an experienced radiologist. 5. Target Gender: Female, age ≥ 18 years 6. Written informed consent. 7. Able to apply with study procedures. 8. Life expectancy > 3 months 9. No contraindication to biopsy as appropriate |
| Key exclusion criteria | 1. Ovarian, primary peritoneal or fallopian tube cancer of non-high grade serous pathology i.e. low grade serous, clear cell and endometrioid as well as carcinosarcoma/Malignant Mixed Mullerian Tumor (MMMT) 2. Borderline/low malignant potential tumours 3. Any non-epithelial ovarian malignancy 4. Patients with asymptomatic rising CA125 with no radiological evidence of recurrent ovarian cancer. 5. Original diagnosis of high grade serous cancer made on cytology only |
| Date of first enrolment | 11/12/2012 |
| Date of final enrolment | 30/08/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Glasgow
G12 0YN
United Kingdom
Sponsor information
NHS Greater Glasgow & Clyde (UK)
Hospital/treatment centre
Hospital/treatment centre
Tennent Building
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom
| Website | http://www.nhsgg.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Ovarian Cancer Action (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | Acquisition of resistance | 20/07/2023 | 20/10/2023 | Yes | No |
| Results article | Safety and utility of image-guided research biopsies | 13/03/2019 | 24/10/2023 | Yes | No |
Editorial Notes
24/10/2023: Publication reference added.
20/10/2023: Publication reference added.
19/02/2020: Cancer Research UK lay results summary link added to Results (plain English).
09/05/2017: The overall trial end date has been updated from 11/12/2015 to 30/08/2018 and the recruitment end date has been updated from 11/12/2015 to 30/08/2017.
