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

Phase 1

Completed

• Conditions: Endometrial Carcinoma
• Interventions: Behavioral: Focus Group; Procedure: Biospecimen Collection; Other: Survey Administration

• Registration Number: NCT04474184
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• AIM 1: Self-identified white women (WW) or African American women (AAW) (will record Hispanic ethnicity)
• AIM 2: Self-reported history of abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB)

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Exclusion Criteria

• AIM 1: Women who do not identify as WW or AAW
• AIM 1: Women who are unable to speak and read English
• AIM 2: Prior hysterectomy
• AIM 2: Prior pelvic radiation or are unwilling to comply with instructions
• AIM 2: Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aim 1 (focus group)	Focus Group	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 (vaginal kit)	Biospecimen Collection	Participants receive a tampon kit for collection of vaginal samples.
Aim 2 (vaginal kit)	Survey Administration	Participants receive a tampon kit for collection of vaginal samples.
Aim 1 (focus group)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Endometrial DNA (Aim 2)	Up to 12 months
Total deoxyribonucleic acid (DNA) (Aim 2)	Up to 12 months
Differences in views on endometrial cancer (EC) risk between African American and white women and whether the former would be willing to participate in tampon testing (Aim 1)	Up to 12 months	Survey data will be reported as frequencies and proportions to describe the sample. Survey data will also be used to aid in interpretation of the qualitative data as appropriate.
Detection of EC-specific methylation markers (Aim 2)	Up to 12 months	Will test samples for top EC-specific DNA methylation markers using methylation-specific polymerase chain reaction and provide descriptive statistics for all measurements (mean, median, standard deviation). Will assess the percentage of samples that yield \> 500 ng amplifiable DNA, which suffices for methylation assays.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States