Targeting Inflammation for Endometrial Cancer Prevention

Active, not recruiting

• Conditions: Endometrial Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT05407025
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To develop a model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations.

OUTLINE: This is an observational study.

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 191

Inclusion Criteria

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, biospecimen collection)	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.
Observational (questionnaire, biospecimen collection)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Levels of eicosanoids and specialized pro-resolving mediators (SPMs) in visceral adipose tissue (VAT)	Through study completion, up to 24 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Ribonucleic acid (RNA) expression pathways related to inflammation in VAT	Through study completion, up to 24 weeks	Will assess RNA data with cluster analysis and principal component analysis, focusing on inflammatory / immune pathways pathways in 10 patients with endometrioid endometrial cancer and 10 patients with benign conditions, frequency matched on age and body mass index (BMI). We will Will assess RNA expression patterns in relation to eicosanoid / SPMs that discriminate cases versus controls.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States