BriTROC1 (The UK Translational Research in Ovarian Cancer Collaborative) - Sample collection study in recurrent high grade serous ovarian cancer (HGSOC)

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube; Cancer; Malignant neoplasm of ovary

• Registration Number: ISRCTN09180474
• Lead Sponsor: HS Greater Glasgow & Clyde (UK)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37474499/ Acquisition of resistance (added 20/10/2023) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30862952/ Safety and utility of image-guided research biopsies (added 24/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-27
• Study Completion: 2018-08-30
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified