Topic: National Cancer Research Network
Conditions
Interventions
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
Sponsors
NHS Greater Glasgow & Clyde (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Scotland, United Kingdom
Outcome results
None listed