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Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates

NCT04474184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-11-18

No results posted yet for this study

Summary

This phase I trial investigates the development of a new early detection test to reduce racial disparities in endometrial cancer death rates. DNA samples collected from a tampon may be able to be used to detect endometrial cancer. Studying information from focus groups and vaginal samples of African American and white women may help researchers develop a less invasive and painful test to detect endometrial cancer. The purpose of this trial is to perform a demonstration project of tampon self-collection, assess percentage of samples returned; total and endometrial derived DNA quantity and quality, preliminarily test previously validated DNA methylation markers that may discriminate endometrial cancer from normal endometrium in tampon specimens.

Conditions

  • Endometrial Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Receive vaginal kit for biospecimen collection

BEHAVIORAL

Focus Group

Attend focus group

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Mark E Sherman, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2023-01-25
Completion
2023-01-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474184 on ClinicalTrials.gov