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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08686 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-006515 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC240602 | Other Identifier | Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood, urine, and endometrial tissue sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of biomarkers with endometrial status | Biomarkers obtained from biospecimen samples will be assessed for correlation with endometrial status in women on low-dose aspirin versus those not taking low-dose aspirin (observational cohort). Biomarker data will be tested in LMMs for significant association with treatment group and change over time. | Baseline to 42 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Caroline Chang | Contact | 904-953-4637 |
| Name | Affiliation | Role |
|---|---|---|
| Christopher C. DeStephano, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Low-Dose Aspirin | Drug | Given PO |
|
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| Patient Observation | Other | Undergo observation |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Ultrasound Imaging | Procedure | Undergo pelvic ultrasound |
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| Baseline to 6 weeks |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D001241 | Aspirin |
| D057832 | Watchful Waiting |
| D019370 | Observation |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D008722 | Methods |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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