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Methylation Markers for Natural History and Early Detection of Endometrial Cancer

45 Years
Open (Enrolling)
Endometrial Cancer, Gynecological Cancers

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Trial Information

Methylation Markers for Natural History and Early Detection of Endometrial Cancer

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 1000
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.

Inclusion Criteria


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

- Prior pelvic radiation

- Cervical stenosis that renders Tao brush sampling impossible

Type of Study:


Study Design:


Outcome Measure:

Endometrial cancer

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nicolas Wentzensen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2013

Completion Date:

December 2015

Related Keywords:

  • Endometrial Cancer
  • Gynecological Cancers
  • Endometrial Cancer
  • Gynecological Cancers
  • Screening
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Mayo Clinic, Rochester Rochester, Minnesota  55905