Brief Title
Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
Official Title
Methylation Markers for Natural History and Early Detection of Endometrial Cancer
Brief 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.
Study Type
Observational
Primary Outcome
Endometrial Cancer and Endometrial Hyper Plasia
Condition
Endometrial Cancer
Study Arms / Comparison Groups
Endometrial Cancer Cohort
Description: Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1932
Start Date
February 11, 2013
Completion Date
November 16, 2020
Primary Completion Date
December 1, 2016
Eligibility Criteria
- 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
EXCLUSION CRITERIA:
- 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
Gender
Female
Ages
45 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Nicolas Wentzensen, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01793545
Organization ID
999913073
Secondary IDs
13-C-N073
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Collaborators
Mayo Clinic
Study Sponsor
Nicolas Wentzensen, M.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
November 2020