Status: Closed
Activation Date: 2018APR06
Closing Date: 2022DEC15
Phase: II
Description: A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)
Eligibility: Women with documented germline BRCA 1/2 mutations, scheduled to undergo risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) within 6 months to 2 years after the date of randomization.
Objective: PRIMARY OBJECTIVE: To compare the frequency of pre- & early-malignant lesions (serous tubal intraepithelial carcinomas (STICs) or serous tubal occult neoplasias - early (STONEs) in the fallopian tube, at the time of risk reducing surgery. SECONDARY OBJECTIVE: To assess subject acceptance of ASA intervention in a female cohort at high risk for ovarian cancer. TERTIARY OBJECTIVES: (1) To characterize the effect of ASA on high grade serous ovarian cancer (HGSOC) tumourigenesis and to examine the linkage between tumourigenesis and microenvironment. (2) Biobanking for future correlative studies
Participation: Open to member centres
Lay Description: The purpose of this randomized phase II trial is to find out whether Acetylsalicylic Acid (ASA), commonly known as Asprin, can prevent or reduce the risk of early ovarian cancer in women at high risk for ovarian cancer (with a high-risk gene mutation, BRCA1 or BRCA2). The researchers will test the tissue samples revmoved by surgery to see if taking ASA before the surgery can reduce the risk of ealry or small cancer. This study will also test some biomarkers that might help predict which women are most likely to be affected by the study drug.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | OV25 | 117 | 0 | 71 | 71 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GYNECOLOGIC | OV25 | 117 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GYNECOLOGIC | OV25 | 117 | 80 | 0 | 0 | 0 | 111 | 95 | 0 | 0 |