Targeting Inflammation for Endometrial Cancer Prevention

NCT05407025 | Active Not Recruiting

• 2 other identifiers: 21-001880NCI-2021-14231
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 2

Brief Summary

This study examines risk assessment and identifies prevention strategies for endometrial cancer. Collecting samples of blood and urine and risk assessments from patients with benign conditions or endometrial cancer may help doctors learn if there is a relationship between chronic inflammation and increase in risk for endometrial cancer.

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Levels of eicosanoids and specialized pro-resolving mediators (SPMs) in visceral adipose tissue (VAT)

  Will compare eicosanoid and SPM levels by case-control status (women with endometrial carcinoma and women with non-cancerous conditions) in all patients with linear models, adjusted for age and body mass index (BMI) (and menstrual date, if needed).

  Through study completion, up to 24 weeks

Secondary Outcomes (1)

• Ribonucleic acid (RNA) expression pathways related to inflammation in VAT

  Through study completion, up to 24 weeks

Study Arms (1)

Observational (questionnaire, biospecimen collection)

Patients complete a risk factor questionnaire over 15 minutes. Patients also undergo collection of blood and urine during pre-operative visit and collection of tissue samples at the time of surgery.

Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood, urine, and tissue samples

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

Observational (questionnaire, biospecimen collection)

Questionnaire Administration OTHER

Complete risk factor questionnaire

Observational (questionnaire, biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing hysterectomy at University of North Carolina (UNC) and Mayo Clinic, Florida

You may qualify if:

• Women over the age of 18 years old undergoing hysterectomy for any benign indication or endometrial cancer

You may not qualify if:

• Men
• Women under the age of 18 years
• Women with a history of cancer, except for endometrial cancer or non-melanoma skin cancer
• Women with type 1 diabetes
• Women that have received radiation or chemotherapy for cancer

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Specimen Handling

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

Study Officials

• Mark E. Sherman, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (2)