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Not yet recruiting NCT07281547

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

Phase IV Interventional Endometrial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Low-Dose Aspirin, Patient Observation, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Endometrial Carcinoma. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo blood, urine, and endometrial tissue sample collection
  • Drug Low-Dose Aspirin
    Given PO
  • Other Patient Observation
    Undergo observation
  • Other Questionnaire Administration
    Ancillary studies
  • Procedure Ultrasound Imaging
    Undergo pelvic ultrasound

Primary outcome measures

  • Change in prostaglandin E2 (PGE2) [Time frame: Baseline to 6 weeks]
Secondary outcome measures (1)
  • Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial [Time frame: Baseline to 6 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07281547 · MC240602 · 24-006515

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗