ClinicalTrials.gg
Active, not recruitingNCT03480776Updated Sep 16, 2026

ASA in Prevention of Ovarian Cancer (STICs and STONEs)

A Phase 2 interventional study of Acetylsalicylic acid and Placebo in Ovarian Cancer Prevention, sponsored by Canadian Cancer Trials Group. Active, not recruiting at 17 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Canadian Cancer Trials Group · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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).

02

Conditions studied

  • Ovarian Cancer Prevention

Browse trials for

03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's enrollment of 117 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Canadian Cancer Trials Group is the lead sponsor of 93 studies on the registry; 29 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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 must have agreed to use a highly effective method for the duration of the study treatment and for 30 days post last dose of study medication

Exclusion criteria

Exclusion Criteria:

  • Subjects with history of other , 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- 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
117 participants (actual)

Study arms

  • Active comparator
    Acetylsalicylic Acid (ASA)

    Drug: Acetylsalicylic acid

  • Sham comparator
    Placebo

    Other: Placebo

Interventions

  • 81 mg PO daily or 325 mg PO daily

    Also known as: ASA

  • OtherPlacebo

    One tablet PO daily

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

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

    Time frame: 5 years

  2. Compliance of taking ASA by serum monitoring

    Time frame: 5 years

Other outcomes

  1. Compliance of taking ASA by evaluation of treatment completion rates

    Time frame: 5 years

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

    Time frame: 5 years

07

Study locations

17 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03480776
Lead sponsor
Canadian Cancer Trials Group
Collaborators
Apotex Inc.
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Jul 24, 2018
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Amit Oza
study chair · Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Stephanie Lheureux
study chair · Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Aspirin

Start the discussion