Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gynecological Cancers Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

45 year–120 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Endometrial Cancer and Endometrial Hyper Plasia

Time frame: 1 to 5 years

Histologically confirmed endometrial cancer or endometrial hyperplasia

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

Mayo Clinic

Registry information

Official study title

Methylation Markers for Natural History and Early Detection of Endometrial Cancer

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2020
First posted: Feb 15, 2013
Registry last updated: Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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