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Nonsteroidal Anti-inflammatory Drug

ASA for Ovarian Cancer Prevention

Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will investigate whether taking ASA reduces the risk of developing ovarian cancer.

Who is the study for?
This trial is for women over 18 with a high risk of ovarian cancer due to BRCA1/2 mutations, who plan to have preventive surgery within 6 months to 2 years. They must be in good health, not pregnant or breastfeeding, and not on blood thinners or anti-inflammatory drugs. Participants should agree to use effective contraception and complete questionnaires in English or French.Check my eligibility
What is being tested?
The study tests if Acetylsalicylic acid (ASA), an anti-inflammatory drug, can prevent ovarian cancer compared to a placebo. Women will be randomly assigned ASA or placebo before their scheduled risk-reducing surgery.See study design
What are the potential side effects?
Possible side effects of ASA include increased bleeding risk, digestive issues like stomach ulcers, allergic reactions especially in those with asthma related to salicylates or NSAIDs, and potential kidney, liver, or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have a confirmed genetic mutation in BRCA1/2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test
Secondary outcome measures
Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire
Compliance of taking ASA by serum monitoring
Other outcome measures
Aspirin
Compliance of taking ASA by reasons for early discontinuation of protocol intervention.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Acetylsalicylic Acid (ASA)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
126 Previous Clinical Trials
67,925 Total Patients Enrolled
Apotex Inc.Industry Sponsor
8 Previous Clinical Trials
28,903 Total Patients Enrolled
Stephanie LheureuxStudy ChairUniv. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
5 Previous Clinical Trials
418 Total Patients Enrolled

Media Library

Acetylsalicylic acid (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03480776 — Phase 2
Ovarian Cancer Prevention Research Study Groups: Placebo, Acetylsalicylic Acid (ASA)
Ovarian Cancer Prevention Clinical Trial 2023: Acetylsalicylic acid Highlights & Side Effects. Trial Name: NCT03480776 — Phase 2
Acetylsalicylic acid (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03480776 — Phase 2
~9 spots leftby Dec 2024
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