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

NCT04474184 | Completed Phase 1

• 2 other identifiers: 19-001140NCI-2020-04756
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Aim 1 (focus group)

EXPERIMENTAL

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; Other: Survey Administration

Aim 2 (vaginal kit)

EXPERIMENTAL

Participants receive a tampon kit for collection of vaginal samples.

Procedure: Biospecimen Collection; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Receive vaginal kit for biospecimen collection

Aim 2 (vaginal kit)

Focus Group BEHAVIORAL

Attend focus group

Aim 1 (focus group)

Survey Administration OTHER

Ancillary studies

Aim 1 (focus group); Aim 2 (vaginal kit)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mark E Sherman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: February 1, 2020
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)