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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

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

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 plan to have surgery to lower my cancer risk within 6 months to 2 years after joining the study.

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I am fully active or can carry out light work.

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I can start the trial treatment within 2 days after being chosen.

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I can and am willing to fill out a questionnaire in English or French.

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I have a confirmed genetic mutation in BRCA1/2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

67,336 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you name a few of the Canadian medical facilities conducting this trial?

"North York General Hospital in Toronto, CIUSSS de l'Estrie - Centre hospitalier in Sherbrooke and Hotel-Dieu de Quebec in Quebec City are among the 12 medical sites offering this trial along with other centres."

Answered by AI

Is this investigation pioneering a new approach to treatment?

"Ever since the initial clinical trial for Acetylsalicylic Acid (ASA) was sponsored by Abbott in 2005, involving 15480 patients, it has moved through drug approval phases and is now in Phase 4. As of today, 169 studies are actively taking place across 57 different nations and 1398 urban centres."

Answered by AI

Has Acetylsalicylic Acid (ASA) been given the green light by the FDA?

"Our team at Power assigns Acetylsalicylic Acid a safety rating of 2, since Phase 2 trials have provided some evidence demonstrating its security but not efficacy."

Answered by AI

Are there still opportunities for individuals to take part in this investigation?

"Affirmative. Clinicaltrials.gov has established that this analysis, which was initially posted on April 6th 2018, is actively recruiting participants. 414 people need to be enrolled from 12 different centres."

Answered by AI

To what end is Acetylsalicylic Acid (ASA) commonly employed?

"Acetylsalicylic Acid (ASA) is typically indicated for percutaneous coronary intervention (pci). But it can also be prescribed to assist with dental procedures, reduce inflammation, and alleviate neck pain."

Answered by AI

What other investigations have been conducted featuring Acetylsalicylic Acid (ASA)?

"Acetylsalicylic Acid (ASA) was first researched in 2005 by the Clinical Trial Service Unit, NDPH at University of Oxford. Since then, 18757 studies have been completed and there are currently 168 medical trials actively seeking participants. Of these trails, a significant portion is being hosted out of Toronto and Quebec."

Answered by AI

How many participants are actively engaged with this trial?

"To satisfy the study's enrollment requirements, Apotex Inc. must enlist a total of 414 compliant volunteers. In order to do so, they will be running clinical trials at North York General Hospital in Toronto and CIUSSS de l'Estrie - Centre hospitalier in Sherbrooke, Alberta."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASA in Prevention of Ovarian Cancer (STICs and STONEs)

2018. "ASA in Prevention of Ovarian Cancer (STICs and STONEs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03480776.

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