Clinical trial · Interventional
ASA in Prevention of Ovarian Cancer (STICs and STONEs)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
While ASA is not a cancer medication, research suggests that taking ASA reduces the probability of getting many types of cancer because of its anti-inflammatory action. Inflammation in the ovaries during ovulation is thought to contribute to the development of ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent it.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetylsalicylic acid | Drug | Aspirin | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acetylsalicylic Acid (ASA)
- interventionNames
- Drug: Acetylsalicylic acid
- type
- SHAM_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines * Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families * ECOG performance status 0 or 1 * Age ≥ 18 years old * Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French. * Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate * Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization * Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication Exclusion Criteria: * Subjects with history of other malignancies, except: * adequately treated non-melanoma skin cancer; * curatively treated in-situ cancer of the cervix; * previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time. * other solid tumours curatively treated with no evidence of disease for \> 5 years. * Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time. * Subjects with active bleeding or bleeding diathesis. * Subjects with active peptic ulcer. * Subjects with renal, hepatic or congestive heart failure. * Subjects with concurrent use of anti-coagulants and/or anti-platelet agents. * Subjects with prior bilateral salpingectomy. * Subjects with history of chronic daily use of ASA or NSAIDs. * Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs. * Ongoing or planned pregnancy. * Subjects who are breastfeeding.
References
Publications (0)
Data not yet available