Targeting Inflammation for Endometrial Cancer Prevention

N/AActive Not RecruitingNCT05407025

Mayo Clinic191 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

191

Conditions

Endometrial Carcinoma

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood, urine, and tissue samples

Questionnaire AdministrationOTHER

Complete risk factor questionnaire

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women over the age of 18 years old undergoing hysterectomy for any benign indication or endometrial cancer 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

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: Through study completion, up to 24 weeks

Secondary Outcomes

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

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.

Time frame: Through study completion, up to 24 weeks

Data from ClinicalTrials.gov

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