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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Behavioral: Focus Group
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1 (focus group)<br>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. | Behavioral: Focus Group<br>* Attend focus group<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Aim 2 (vaginal kit)<br>Participants receive a tampon kit for collection of vaginal samples. | Procedure: Biospecimen Collection<br>* Receive vaginal kit for biospecimen collection<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total deoxyribonucleic acid (DNA) (Aim 2) |  | Up to 12 months | 
| Endometrial DNA (Aim 2) |  | Up to 12 months | 
| 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 |