Clinical trial NCT04474184: Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates
Official title: Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometrial Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 33
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Up to 12 months
measure: Total deoxyribonucleic acid (DNA) (Aim 2)
timeFrame: Up to 12 months
measure: Endometrial DNA (Aim 2)
timeFrame: Up to 12 months
measure: Detection of EC-specific methylation markers (Aim 2)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mark E Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: