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Ovarian Cancer PreventionPhase 2NCT03480776

ASA in Prevention of Ovarian Cancer (STICs and STONEs)

A Phase 2 study testing Acetylsalicylic acid in people with Ovarian Cancer Prevention, run by Canadian Cancer Trials Group at 17 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer Prevention
What is being tested?
Acetylsalicylic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
17 sitesin 2 countries
Study dates
24 Jul 2018to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

Canada11 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

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

    Montreal, Quebec, H1T 2M4

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

  • Dr. H. Bliss Murphy Cancer Centre

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

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

  • Clinical Research Unit at Vancouver Coastal

    Vancouver, British Columbia, V5Z 1M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Peter McCallum Cancer Institute

    Melbourne, Victoria, 3002

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • King Edward Memorial Hospital

    Subiaco, Western Australia, 6008

  • St John of God Subiaco

    Subiaco, Western Australia, 6008

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: 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)

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.

Read the detailed description

The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally.

Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken by mouth. ASA has been available for over 100 years and has been used mainly to relieve fever and pain, but also as an anti-inflammatory medication in order to reduce inflammation (swelling).

Being tested
Acetylsalicylic acid, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetylsalicylic acidDrug

    Also called ASA

    81 mg PO daily or 325 mg PO daily

  • PlaceboOther

    One tablet PO daily

Study groups in NCT03480776
Study groupRoleWhat they receive
Acetylsalicylic Acid (ASA)Active comparatorNot described
Receives: Drug: Acetylsalicylic acid
PlaceboSham comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 years

Secondary outcomes (2)

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

    Measured: 5 years

  2. Compliance of taking ASA by serum monitoring

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start24 Jul 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480776
Sponsor's protocol ID
OV25
Status last verified
Jan 2026
First submitted
14 Mar 2018
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetylsalicylic acid in people with Ovarian Cancer Prevention, run by Canadian Cancer Trials Group at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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