Endometrial Cancer Clinical Trial
Official title:
Preliminary Study of Endometrial Hyperplasia: Groundwork for a Study to Define an Optimal Classification of Endometrial Carcinoma Precursors
Verified date | August 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 745 |
Est. completion date | August 6, 2020 |
Est. primary completion date | August 6, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 120 Years |
Eligibility |
- INCLUSION CRITERIA: All women who were members of the KPNW health plan between 1970 and 2003 who were at risk of developing endometrial carcinoma will be eligible. EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Northwest | Hillsboro | Oregon |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Baak JP, Ørbo A, van Diest PJ, Jiwa M, de Bruin P, Broeckaert M, Snijders W, Boodt PJ, Fons G, Burger C, Verheijen RH, Houben PW, The HS, Kenemans P. Prospective multicenter evaluation of the morphometric D-score for prediction of the outcome of endometrial hyperplasias. Am J Surg Pathol. 2001 Jul;25(7):930-5. — View Citation
Bergeron C, Nogales FF, Masseroli M, Abeler V, Duvillard P, Müller-Holzner E, Pickartz H, Wells M. A multicentric European study testing the reproducibility of the WHO classification of endometrial hyperplasia with a proposal of a simplified working classification for biopsy and curettage specimens. Am J Surg Pathol. 1999 Sep;23(9):1102-8. — View Citation
Skov BG, Broholm H, Engel U, Franzmann MB, Nielsen AL, Lauritzen AF, Skov T. Comparison of the reproducibility of the WHO classifications of 1975 and 1994 of endometrial hyperplasia. Int J Gynecol Pathol. 1997 Jan;16(1):33-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endometrial cancer and endometrial hyperplasia. | Formalin fixed paraffin embedded tissue blocks and pathology slides from women with endometrial cancer and women with endometrial hyperplasia with covariate data from medical records. | Cases were diagnosed between 2003 and 2012. Tissue collection is ongoing |
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