The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons

Endometrial Cancer Clinical Trial

Official title: The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons

Status Recruiting

Clinical Trial Summary

Background:

Endometrial cancer is a common and deadly cancer for women. It is getting more common and deadly because risk factors like age and obesity are increasing. It is highly curable if it is identified early. But there may be no symptoms early or they may be missed. Also, this cancer is becoming more common and deadly for black women than white women. Researchers want to find better ways to take samples and test them for this cancer. They want to study this for a racially diverse population. One way to take samples might be from a tampon.

Objective:

To see if it is possible and acceptable to collect an endometrial sample from women by using a tampon placed in the vagina.

Eligibility:

Women at least 45 years old who are having a hysterectomy

Design:

Participants will put a tampon in their vagina at least 30 minutes before their surgery.

Participants will take a short survey.

The tampon will be collected during the surgery.

A small piece of tissue will be collected from the uterus that is removed in surgery.

Participants will give a blood sample.

Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race.

Researchers will follow participants medical records for up to 3 years after the study.

Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.

Clinical Trial Description

BACKGROUND:

• Endometrial cancer is the most common and second deadliest gynecological cancer in women in the United States, with over 63,000 new cases and 11,000 deaths expected to occur in 2018. Unlike most cancers, endometrial cancer incidence and mortality are increasing, due to increases in risk factors such as obesity and population aging.

• Racial disparities in endometrial cancer incidence and mortality have been reported, with black or African American (henceforth referred to as black ) women experiencing more rapid increases in incidence, as well as a higher burden of endometrial cancer mortality compared to other racial/ethnic groups. The underlying basis for these disparities is likely multifactorial, involving biological differences, as well as clinical factors related to access to care, delayed diagnosis, and differences in treatment and surgical management.

• If identified early, endometrial cancer can be highly curable; however, the earliest stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive molecular testing approaches with non-invasive sampling techniques may to lead to the development of novel endometrial cancer early detection approaches with the potential to overcome disparities in access to care and time to diagnosis and treatment. We and others have recently shown that vaginal tampons offer an acceptable and feasible method for identifying molecular markers with high sensitivity and specificity for endometrial cancer. Importantly, these proof-of-principle studies have been conducted in predominantly non-Hispanic white (white) populations, and studies of molecular markers for endometrial cancer, including those involving vaginal tampons, are lacking in black women.

OBJECTIVES:

-The goal of this study is to evaluate the acceptability, feasibility, and clinical performance of vaginal tampon sampling for molecular testing of endometrial cancer early detection biomarkers in a racially diverse clinical population.

ELIGIBILITY:

-Eligible participants will include women aged greater than or equal to 45 years undergoing clinically-indicated hysterectomy for endometrial cancer, endometrial cancer precursors, or benign conditions at the University of Alabama s Division of Gynecologic Oncology.

DESIGN:

• This is a case-control study with prospective follow-up of the electronic health record or up to 3 years. Cases will be defined as women with histologically-confirmed endometrial cancer or cancer precursors diagnosed at hysterectomy. Controls will have no histologic evidence of endometrial cancer or endometrial cancer precursors diagnosed at hysterectomy.

• The primary endpoints of this study will be: 1) The acceptability and feasibility of vaginal tampon sampling in a racially diverse clinical population, assessed by evaluating approximately 10 items from a brief survey regarding tampon sampling and the DNA yield from the vaginal tampon, respectively and 2) The prevalence, sensitivity, and specificity of endometrial cancer driver mutations in tampon and tissue samples in cases and controls. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Cancer Precursors
• Endometrial Neoplasms

• NCT number: NCT03538665
• Study type: Observational
• Source: University of Alabama at Birmingham
• Contact: Rebecca C Arend, MD
• Phone: (917) 532-5370
• Email: rarend@uabmc.edu
• Status: Recruiting
• Start date: July 1, 2019
• Completion date: August 11, 2025