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 |
| Protocol serial number | 13727 |
| Sponsor | NHS Greater Glasgow & Clyde (UK) |
| Funder | Ovarian Cancer Action (UK) |
- 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
Plain English summary of protocol
Contact information
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
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre centre non-randomised sample collection observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Assessment of mutations in HRD genes, BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, in relapsed HGSOC samples by targeted sequencing |
| Completion date | 30/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Glasgow
G12 0YN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
