NCT04474184

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

Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To conduct focus groups to elicit perceptions and knowledge among African American women (AAW) and white women (WW) concerning abnormal uterine bleeding (AUB)/post-menopausal bleeding (PMB), endometrial cancer (EC) risk factors, barriers to seeking medical evaluation, sources of medical information and acceptance and feasibility of tampon self-collection for laboratory testing. II. To perform a demonstration project of tampon self-collection from 25 AAW and 25 WW with AUB/PMB in Jacksonville. OUTLINE: AIM 1: Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection. AIM 2: Participants receive a tampon kit for collection of vaginal samples. After completion of study enrollment, participants may be followed up annually for 10 years.

Conditions

• Endometrial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Receive vaginal kit for biospecimen collection
BEHAVIORAL	Focus Group	Attend focus group
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2020-02-01
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2020-07-16
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States