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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
Must not have
Subjects with concurrent use of anti-coagulants and/or anti-platelet agents
Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking blood thinners or anti-platelet medications.
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I have been treated with a PARP-inhibitor like olaparib.
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I have a condition that causes me to bleed easily.
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I currently have an active peptic ulcer.
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I have kidney, liver problems, or heart failure.
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I regularly take aspirin or NSAIDs daily for a chronic condition.
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I have had both of my fallopian tubes surgically removed.

Timeline

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

Treatment Details

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
132 Previous Clinical Trials
69,750 Total Patients Enrolled
2 Trials studying Ovarian Cancer
335 Patients Enrolled for Ovarian Cancer
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 Research Study Groups: Placebo, Acetylsalicylic Acid (ASA)
Ovarian Cancer 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
~0 spots leftby Dec 2024
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