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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Endometrial Cancer, Endometrial Cancer Precursors

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Women scheduled for hysterectomy for endometrial cancer, endometrial cancer precursors, or benign conditions at the University of Alabama Birmingham s Division of Gynecologic Oncology. Age greater than or equal to 45 years. We have chosen this age range to include both peri- and postmenopausal women, who are at greatest risk for endometrial cancer. Women younger than 45 years of age will not be included because they are at very low risk for endometrial cancer and therefore are likely not the target population for early detection of endometrial cancer. Ability of subject to understand and the willingness to sign a written informed consent document. Women who do not meet this criterion include potential participants who do not speak English, or have physical, mental, or emotional problems that prevent them from comprehending the nature of the study. If the potential participant has trouble reading the document, the designated study staff person may read the document to the patient, to include the basic elements of the informed consent document, per 45 CFR 46.116 (a). EXCLUSION CRITERIA: Women who are pregnant are excluded from gynecologic surgery and are therefore not eligible to participate. Men are not eligible for this study as this is a disease of a female organ.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Women undergoing clinically-indicated hysterectomy for endometrial cancer or precursors | |
| Controls<br>Women undergoing clinically-indicated hysterectomy for benign conditions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Cancer | Women with histologically confirmed diagnosis of endometrial cancer | Enrollment or at time of surgery | 
| Endometrial cancer precursors | Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia) | Enrollment or at time of surgery | 
| Non-malignant uterus | Women with fibroids, polyps, endometrial hyperplasia without atypia, adenomyosis, normal endometrium, or other benign conditions determined by histology and/or clinical imaging. | Enrollment or at time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of tampon sampling | Women will be given a 10 question survey to assess acceptability of tampon sampling | Prior to surgery | 
| Feasibility of tampon sampling | The feasibility of tampon sampling will be determined by successful tampon insertion according to protocol prior to surgery and sufficient DNA yield (e.g., 1-2 microgram) from the tampon sample. | During and immediately after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Cancer, Somatic Mutations, Early Detection, Tampon Sampling, Tissue Discovery, Natural History