Targeting Inflammation for Endometrial Cancer Prevention

Endometrial Carcinoma Clinical Trial

Official title:

Targeting Inflammation for Endometrial Cancer Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05407025
• Other study ID #: 21-001880
• Secondary ID: NCI-2021-14231
• Status: Active, not recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 191
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Carcinoma
• Endometrial Neoplasms
• Inflammation

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, urine, and tissue samples

Other:
• Questionnaire Administration
Complete risk factor questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Through study completion, up to 24 weeks

External Links

•   Mayo Clinic Clinical Trials