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

Endometrial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474184
• Other study ID #: 19-001140
• Secondary ID: NCI-2020-04756
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2020
• Est. completion date: January 25, 2023

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Carcinoma
• Endometrial Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Receive vaginal kit for biospecimen collection

Behavioral:
• Focus Group
Attend focus group

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Up to 12 months
Primary	Total deoxyribonucleic acid (DNA) (Aim 2)		Up to 12 months
Primary	Endometrial DNA (Aim 2)		Up to 12 months
Primary	Detection of EC-specific methylation markers (Aim 2)	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.	Up to 12 months