NCT03480776

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
4mo left

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
2 countries

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2018Sep 2026

First Submitted

Initial submission to the registry

March 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

7.9 years

First QC Date

March 14, 2018

Last Update Submit

January 12, 2026

Conditions

Ovarian Cancer Prevention

Outcome Measures

Primary Outcomes (1)

  • Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test

    5 years

Secondary Outcomes (2)

  • Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire

    5 years

  • Compliance of taking ASA by serum monitoring

    5 years

Other Outcomes (2)

  • Compliance of taking ASA by evaluation of treatment completion rates

    5 years

  • Compliance of taking ASA by reasons for early discontinuation of protocol intervention.

    5 years

Study Arms (2)

Acetylsalicylic Acid (ASA)

ACTIVE COMPARATOR
Drug: Acetylsalicylic acid

Placebo

SHAM COMPARATOR
Other: Placebo

Interventions

Acetylsalicylic acidDRUG

81 mg PO daily or 325 mg PO daily

Also known as: ASA
Acetylsalicylic Acid (ASA)
PlaceboOTHER

One tablet PO daily

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Peter McCallum Cancer Institute

Melbourne, Victoria, 3002, Australia

Location

King Edward Memorial Hospital

Subiaco, Western Australia, 6008, Australia

Location

St John of God Subiaco

Subiaco, Western Australia, 6008, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Clinical Research Unit at Vancouver Coastal

Vancouver, British Columbia, V5Z 1M9, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

CIUSSS de l'Est-de-I'lle-de-Montreal

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Amit Oza

    Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

    STUDY CHAIR

  • Stephanie Lheureux

    Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 29, 2018

Study Start

July 24, 2018

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(11)AU(6)