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Targeting Inflammation for Endometrial Cancer Prevention

Targeting Inflammation for Endometrial Cancer Prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05407025
Enrollment
191
Registered
2022-06-07
Start date
2021-12-01
Completion date
2027-12-31
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Carcinoma

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood, urine, and tissue samples

OTHERQuestionnaire Administration

Complete risk factor questionnaire

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Levels of eicosanoids and specialized pro-resolving mediators (SPMs) in visceral adipose tissue (VAT)Through study completion, up to 24 weeksWill 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

MeasureTime frameDescription
Ribonucleic acid (RNA) expression pathways related to inflammation in VATThrough study completion, up to 24 weeksWill 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026