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Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

NCT01793545 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1932

Last updated 2020-11-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicolas Wentzensen, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
45 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-11
Primary Completion
2016-12-01
Completion
2020-11-16

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793545 on ClinicalTrials.gov