Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer
Completed
Conditions studied: Endometrial Hyperplasia, Endometrial Cancer, Postmenopausal Bleeding, Vaginal Bleeding
In brief
This study, conducted jointly by the National Cancer Institute and the Kaiser Permanente Center for Health Research Northwest (KPCHRN) in Portland, Oregon, will lay the groundwork for a future study to identify precursors of endometrial cancer; that is, conditions that precede development of cancer of the lining of the uterus. The diagnosis of endometrial hyperplasia (a condition of abnormal proliferation of endometrial tissue) includes most precursors of endometrial cancer, as well as many benign conditions. Currently, three methods of classifying endometrial cancer precursors have been suggested based on endometrial hyperplasia findings, but it is not known which classification best predicts cancer risk. This study will examine surgical specimens of hyperplasia and cancer from women diagnosed with endometrial cancer at least 2 years after a diagnosis of endometrial hyperplasia. Investigators will estimate the percentage of cases with different degrees of hyperplasia, and assess the subsequent cancers that developed. This will allow them to rank hyperplasia lesions according to cancer risk and identify lesions that represent the most immediate cancer precursors. They will also review patients medical charts for information related to cancer risk and treatment. Study participants will include women enrolled in the KPCHRN who are 40 years of age or older and who were diagnosed with endometrial cancer at least 2 years after being diagnosed with endometrial hyperplasia.
Key facts
- Study ID
- NCT00339651
- Run by
- National Cancer Institute (NCI)
- People needed
- 745
- Starts
- 2002-11-25
- Expected to finish
- 2020-08-06
- Last updated by the study team
- 2020-08-14
Who can join
Age: 40 and older, up to 120. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Women will be considered ineligible if they had substantial gaps in KPNW coverage during the years between the index biopsy and diagnosis date (cases) or censoring date (controls).
- NCI and KPNW will review otherwise eligible women who have coverage gaps to identify substantial gaps and determine eligibility on an individual basis.
Where it is running
- Kaiser Permanente Northwest — Hillsboro, Oregon, United States
Full record on ClinicalTrials.gov
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