Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain

NCT07281547 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: MC240602NCI-2025-0868624-006515
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 weeks

Secondary Outcomes (1)

• Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial

  Baseline to 6 weeks

Other Outcomes (1)

• Correlation of biomarkers with endometrial status

  Baseline to 42 days

Study Arms (2)

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.

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.

Procedure: Biospecimen Collection; Other: Patient Observation; Other: Questionnaire Administration; Procedure: Ultrasound Imaging

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (low dose aspirin); Arm II (observation)

Ultrasound Imaging PROCEDURE

Undergo pelvic ultrasound

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Arm I (low dose aspirin); Arm II (observation)

Biospecimen Collection PROCEDURE

Undergo blood, urine, and endometrial tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (low dose aspirin); Arm II (observation)

Low-Dose Aspirin DRUG

Given PO

Also known as: Baby Aspirin

Arm I (low dose aspirin)

Patient Observation OTHER

Undergo observation

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Arm II (observation)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Specimen Handling; Aspirin; Watchful Waiting; Observation; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christopher C. DeStephano, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Caroline Chang

CONTACT

904-953-4637

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): August 12, 2026
• Primary Completion (Estimated): June 11, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)