Clincosm LogoSign in Get a demo

Targeting Inflammation for Endometrial Cancer Prevention

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05407025
Collaborator
National Cancer Institute (NCI) (NIH)
50
Enrollment
1
Location
23
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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 risk of endometrial cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Targeting Inflammation for Endometrial Cancer Prevention
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Observational (questionnaire, 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.

Procedure: Biospecimen Collection
Undergo collection of blood, urine, and tissue samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

    • Other: Questionnaire Administration
    Complete risk factor questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. 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 with linear models, adjusted for age and body mass index (BMI) (and menstrual date, if needed).

    Secondary Outcome Measures

    1. 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. We will assess RNA expression patterns in relation to eicosanoid / SPMs that discriminate cases versus controls.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mark E Sherman, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05407025
    Other Study ID Numbers:
    • 21-001880
    • NCI-2021-14231
    • 21-001880
    • P30CA015083
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Inflammation

    Study Results

    No Results Posted as of Jun 7, 2022