Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

November 16, 2020 updated by: National Cancer Institute (NCI)

Methylation Markers for Natural History and Early Detection of Endometrial Cancer

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1932

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with abnormal bleeding or other conditions associated with increased risk of endometrial cancer.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial Cancer and Endometrial Hyper Plasia
Time Frame: 1 to 5 years
Histologically confirmed endometrial cancer or endometrial hyperplasia
1 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999913073
  • 13-C-N073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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