Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
Condition: Endometrial Cancer; Gynecological Cancers
MeSH terms: Endometrial Neoplasms
Study type: Observational

Summary: 
      Background:

      - Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an
      early stage, it can be treated more easily. Women who have this type of cancer often have a
      history of irregular menstrual bleeding. They may also have abnormal findings during
      gynecologic exams. Pap smears and cervical cell collection may be able to collect cell
      samples for cancer testing. However, samples from the vagina or endometrium may produce more
      accurate results. Researchers want to collect vaginal and endometrial cell samples to improve
      their tests for and understanding of endometrial cancer.

      Objectives:

      - To collect vaginal and endometrial cell samples to study endometrial cancer.

      Eligibility:

      - Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal
      bleeding, or abnormal ultrasound findings.

      Design:

        -  Participants will be screened with a physical exam and medical history.

        -  Participants will have a pelvic exam. Before the exam, they will insert a small tampon
           in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will
           then be removed and collected for the study.

        -  During the pelvic exam, tissue will be collected from the uterine lining with a special
           brush. An additional sample (biopsy) will be collected from the lining.

        -  A blood sample will also be collected as part of the study.
    

Detailed description: 
      Endometrial cancer will account for approximately 47,310 incident cases and 8,010 related
      deaths in 2012. Most endometrial cancers develop slowly through progression of well
      characterized precursors, many of which regress with progesterone treatment or are curable
      with hysterectomy. Thus, early detection of endometrial cancer precursors can prevent many
      endometrial cancers and reduce mortality. Using DNA methylation profiling in the Polish
      Endometrial Cancer Study (PECS) and the Benign Reproductive Tissue Evaluation (BRTE) Study,
      we identified a panel of markers that is strongly and specifically linked to endometrial
      cancer. Concurrently, we have developed two sampling methods for detecting endometrial cancer
      and its precursors via DNA methylation analysis: vaginal tampons and endometrial brushings.
      Preliminary data demonstrate that DNA methylation markers are detectable in tampons and
      endometrial brushings and can identify women with endometrial cancer. We propose to extend
      the effort by collecting vaginal tampons and endometrial brushings from about 2000 women who
      are at increased risk of endometrial cancer and who present at the Mayo Clinic Division of
      Medical Gynecology. We will test our candidate panel of DNA methylation markers in this
      population and evaluate the clinical performance to detect endometrial hyperplasia and
      endometrial cancer. Success of this project could lead to development of early detection
      tests, including self-sampling strategies that would improve management of abnormal vaginal
      bleeding, endometrial cancer and its precursors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with abnormal bleeding or other conditions associated with increased risk of
        endometrial cancer.
      
Keywords: Endometrial Cancer; Gynecological Cancers; Screening