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OpenTrials
Active, Not Recruiting

NCT Number: NCT05407025

Targeting Inflammation for Endometrial Cancer Prevention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood, urine, and tissue samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Questionnaire Administration

Other

Complete risk factor questionnaire

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 7, 2022
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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