The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons
Condition: Endometrial Cancer; Endometrial Cancer Precursors
MeSH terms: Endometrial Neoplasms
Study type: Observational

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.
    

Detailed 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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women undergoing clinically-indicated hysterectomy for endometrial cancer, cancer
        precursors, or benign uterine conditions at the University of Alabama Division of
        Gynecologic Oncology who are age 45 years and older.
      
Keywords: Endometrial Cancer; Somatic Mutations; Early Detection; Tampon Sampling; Tissue Discovery; Natural History