Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
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|ClinicalTrials.gov Identifier: NCT01793545|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : November 17, 2020
- 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.
- To collect vaginal and endometrial cell samples to study endometrial cancer.
- Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings.
- 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.
|Condition or disease|
|Endometrial Cancer Gynecological Cancers|
|Study Type :||Observational|
|Actual Enrollment :||1932 participants|
|Official Title:||Methylation Markers for Natural History and Early Detection of Endometrial Cancer|
|Actual Study Start Date :||February 11, 2013|
|Actual Primary Completion Date :||December 1, 2016|
|Actual Study Completion Date :||November 16, 2020|
Endometrial Cancer Cohort
Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer.
- Endometrial Cancer and Endometrial Hyper Plasia [ Time Frame: 1 to 5 years ]Histologically confirmed endometrial cancer or endometrial hyperplasia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793545
|United States, Minnesota|
|Mayo Clinic, Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Nicolas Wentzensen, M.D.||National Cancer Institute (NCI)|