Endometrial CarcinomaPhase 4NCT07281547
Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain
A Phase 4 study testing Biospecimen Collection, Low-Dose Aspirin and Patient Observation in people with Endometrial Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase IV trial studies whether low dose aspirin can be used to lower inflammation and prevent endometrial cancer in postmenopausal women with changes in the endometrial tissue that are not related to thinning (non-atrophic endometrial changes) and pain. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- Biospecimen Collection, Low-Dose Aspirin and Patient Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2027to 11 Jun 2028
- Phase
- Phase 4
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PRE-REGISTRATION: Postmenopausal women
- PRE-REGISTRATION: Transvaginal ultrasound
- PRE-REGISTRATION: Scheduled endometrial biopsy
- PRE-REGISTRATION: Provide risk factor survey
- REGISTRATION: Postmenopausal (defined clinically by no period for over 1 year or postmenopausal follicle-stimulating hormone [FSH], estradiol, or anti-Mullerian hormone [AMH] levels due to natural, medical, or surgical causes)
- REGISTRATION: Have pain (an indicator of inflammation) and other findings warranting endometrial sampling (postmenopausal bleeding [PMB], incidentally noted thickened endometrium > 4mm on ultrasound, obesity, fibroids)
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- REGISTRATION: Capable of providing informed consent
- REGISTRATION: Understands English or Spanish language for consent and questionnaires
- REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
- REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
- REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
- REGISTRATION: Willingness to provide mandatory urine sample for correlative research
Who cannot join
- PRE-REGISTRATION: Not postmenopausal person born with uterus
- PRE-REGISTRATION: Atrophic endometrium
- PRE-REGISTRATION: No uterus
- PRE-REGISTRATION: Malignancy found
- REGISTRATION: Patients with previous hysterectomy (removal of the uterus)
- REGISTRATION: Atrophic endometrium on endometrial sampling performed clinically
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- REGISTRATION: Patients from outside the Mayo Clinic Comprehensive Cancer Center (MCCCC) area
- REGISTRATION: Clinically contraindicated to discontinue use of anticoagulation other than aspirin
- REGISTRATION: Contraindication to use of nonsteroidal anti-inflammatory drugs (NSAIDs) or previous adverse reaction or intolerance to NSAIDs
- REGISTRATION: History of uterine, cervical, or ovarian cancers or precancers (endometrial hyperplasia, cervical dysplasia, fallopian tube intraepithelial carcinoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caroline Chang contact
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, mayocliniccancerstudies@mayo.edu
Caroline Chang, 904-953-4637
About this study
Official title: Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes
This phase IV trial studies whether low dose aspirin can be used to lower inflammation and prevent endometrial cancer in postmenopausal women with changes in the endometrial tissue that are not related to thinning (non-atrophic endometrial changes) and pain. As people age, there is an accumulation of fats, cell death, and inflammation, which causes a surge of pro-cancer-causing events. It is thought that there are several factors involved in the development of endometrial cancer, but that managing the inflammation may address the root cause. Low dose aspirin is aspirin that contains a lower dose than a standard adult tablet. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. Aspirin belongs to the family of drugs called nonsteroidal anti-inflammatory agents. It is also being studied in cancer prevention. Giving low dose aspirin may be an effective way to lower inflammation and prevent endometrial cancer in postmenopausal women with non-atrophic endometrial changes and pain.
- Conditions
- Endometrial Carcinoma
- Being tested
- Biospecimen Collection, Low-Dose Aspirin, Patient Observation, Questionnaire Administration, Ultrasound Imaging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood, urine, and endometrial tissue sample collection
Low-Dose AspirinDrug
Also called Baby Aspirin
Given PO
Patient ObservationOther
Also called Active Surveillance, deferred therapy, expectant management, Observation
Undergo observation
Questionnaire AdministrationOther
Ancillary studies
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo pelvic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Arm I (low dose aspirin) | Experimental | Participants receive low dose aspirin PO QD for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Questionnaire Administration; Procedure: Ultrasound Imaging |
| Arm II (observation) | Active comparator | Participants undergo observation for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Other: Patient Observation; Other: Questionnaire Administration; Procedure: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prostaglandin E2 (PGE2)
Assessed by repeated tissue sampling of the endometrium and compared between treatment and observation groups. A linear mixed-effects model (LMM) will be used to compare the change in PGE2 levels obtained from paired endometrial sampling between two groups of patients (aspirin versus [vs.] no aspirin). The continuous time that elapses between sampling will be assessed together with the binary patient group (aspirin vs. no aspirin) to investigate the change in continuous PGE2 measurement.
Measured: Baseline to 6 weeks
Secondary outcomes (1)
Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial
Assessed at baseline (after consent to participate) using a questionnaire developed for this study: Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial. The survey consists of 7 questions evaluating motivation for participating, barriers to participating, and expectations and understanding of study outcomes. Questions can be answered with one of the listed multiple choice options or with an open-ended "other" option. Post-study data collection will be completed via interview using questions similar to the baseline survey. Results will be analyzed and reported descriptively.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start12 Feb 2027 (estimated)
- Primary completion11 Jun 2028 (estimated)
- Study completion11 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher C. DeStephano, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281547
- Sponsor's protocol ID
- MC240602
- Other IDs
- 24-006515
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No