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

NCT ID: NCT07281547

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-12

Study Completion Date

2028-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm II (observation)

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood, urine, and endometrial tissue sample collection

Patient Observation

Intervention Type OTHER

Undergo observation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Ultrasound Imaging

Intervention Type PROCEDURE

Undergo pelvic ultrasound

Arm I (low dose aspirin)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood, urine, and endometrial tissue sample collection

Low-Dose Aspirin

Intervention Type DRUG

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Ultrasound Imaging

Intervention Type PROCEDURE

Undergo pelvic ultrasound

Interventions

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Biospecimen Collection

Undergo blood, urine, and endometrial tissue sample collection

Intervention Type PROCEDURE

Low-Dose Aspirin

Given PO

Intervention Type DRUG

Patient Observation

Undergo observation

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Ultrasound Imaging

Undergo pelvic ultrasound

Intervention Type PROCEDURE

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Baby Aspirin Active Surveillance deferred therapy expectant management Observation Watchful Waiting 2-Dimensional Grayscale Ultrasound Imaging 2-Dimensional Ultrasound Imaging 2D-US Ultrasonography Ultrasound Ultrasound Test Ultrasound, Medical US

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher C. DeStephano, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Caroline Chang

Role: CONTACT

Phone: 904-953-4637

Facility Contacts

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Clinical Trials Referral Office

Role: primary

Caroline Chang

Role: backup

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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NCI-2025-08686

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-006515

Identifier Type: OTHER

Identifier Source: secondary_id

MC240602

Identifier Type: OTHER

Identifier Source: secondary_id

MC240602

Identifier Type: -

Identifier Source: org_study_id