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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Endometrial Carcinoma

Treatments: Other: Survey Administration; Behavioral: Focus Group; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04474184

19-001140 (Other Identifier)

NCI-2020-04756 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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)

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Aim 1 (focus group)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Behavioral: Focus Group

Aim 2 (vaginal kit)

Experimental group

Description:

Participants receive a tampon kit for collection of vaginal samples.

Treatment:

Other: Survey Administration

Procedure: Biospecimen Collection