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Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01793545
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : November 17, 2020
Mayo Clinic
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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.


- To collect vaginal and endometrial cell samples to study endometrial cancer.


- Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings.


  • 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.

Condition or disease
Endometrial Cancer Gynecological Cancers

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.

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Study Type : Observational
Actual Enrollment : 1932 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methylation Markers for Natural History and Early Detection of Endometrial Cancer
Actual Study Start Date : February 11, 2013
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : November 16, 2020

Endometrial Cancer Cohort
Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer.

Primary Outcome Measures :
  1. Endometrial Cancer and Endometrial Hyper Plasia [ Time Frame: 1 to 5 years ]
    Histologically confirmed endometrial cancer or endometrial hyperplasia

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with abnormal bleeding or other conditions associated with increased risk of endometrial cancer.

Women should meet at least one of the following criteria:

  • Abnormal uterine bleeding
  • Postmenopausal bleeding
  • Thickened endometrial stripe
  • Hereditary predisposition to endometrial cancer (e.g. HNPCC)
  • Women referred for endometrial biopsy to evaluate suspicion or high risk of endometrial cancer


  • Prior hysterectomy
  • Pregnant women (There will be a verbal screen by the clinic nurse and the physician about a potential pregnancy and a pregnancy test may be conducted if there is any doubt)
  • Prior pelvic radiation
  • Cervical stenosis that renders Tao brush sampling impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01793545

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United States, Minnesota
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Mayo Clinic
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Principal Investigator: Nicolas Wentzensen, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01793545    
Other Study ID Numbers: 999913073
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Endometrial Cancer
Gynecological Cancers
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases