Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 24-006515
Sponsor Protocol Number: MC240602
About this study
This pilot, two-arm, randomized study will assess the feasibility of measuring the efficacy of aspirin, compared with observation, for reducing PGE2 and a subset of factors in paired biopsies of endometrium tissue from post-menopausal women. Eligible participants will undergo two endometrial biopsies (i.e. baseline, week-6, or sooner if chosen through shared decision making) separated by 6 weeks (+/- 7 days).
At both timepoints, blood and urine will also be collected to investigate mechanisms of tissue changes. As secondary aims, additional biomarker testing of paired biospecimens (urine, blood, and tissue) will be conducted to assess the correlation of results with treatment group, and clinicopathologic status of the endometrium (i.e. PMB and endometrial thickening). Also, correlations between collected urine, blood, and tissue measures will be explored.
Based on prior knowledge that age and body composition play a role in mechanisms related to endometrial status, sub-group analyses of the primary and secondary endpoints will be conducted. Additional sub-groups in race and ethnicity will be explored as the data allow, due to known differences in endometrial cancer mortality.
Finally, qualitative interviews will be utilized to investigate feasibility of future clinical trials in the community.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Pre-Registration:
Inclusion:
- Women Age ≥45 years
- Postmenopausal Women
- Transvaginal Ultrasound
- Scheduled Endometrial biopsy
- Provide risk factor survey
Exclusion:
- Not postmenopausal person born with uterus
- Atrophic Endometrium
- No uterus
- Malignancy found
Registration:
Inclusion:
- Female Age ≥45 years
- Postmenopausal (defined clinically by no period for over 1 year or postmenopausal FSH and estradiol levels due to natural, medical, or surgical causes)
- Have clinical findings warranting endometrial sampling (PMB or incidentally noted thickened endometrium >4mm on ultrasound)
- Capable of providing informed consent.
- Understands English or Spanish language for consent and questionnaires
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to provide mandatory blood specimens for correlative research
- Willingness to provide mandatory tissue specimens for correlative research
- Willingness to provide mandatory urine sample for correlative research
Exclusion:
- Patients with previous hysterectomy (removal of the uterus)
- Atrophic endometrium on endometrial sampling performed clinically
- Patients from outside the MCCCC area
- Clinically contraindicated to discontinue use of anticoagulation other than aspirin
- Contraindication to use of NSAIDs or previous adverse reaction or intolerance to NSAIDs
- History of uterine, cervical, or ovarian cancers or precancers (endometrial hyperplasia, cervical dysplasia, fallopian tube intraepithelial carcinoma)
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/15/2024. Questions regarding updates should be directed to the study team contact.