Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer

NCT00339651 | Completed

• 2 other identifiers: 99990305303-C-N053
• Study Type: observational
• Target: 745
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Hyperplasia; Endometrial Cancer; Postmenopausal Bleeding; Vaginal Bleeding

Keywords

Precursors; Endometrial Cancer; Hyperplasia; Progression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cases

Women in one large U.S. health care plan. Cases will consist of women who developed endometrial carcinoma or censored complex atypical hyperplasia at least 1 year after receiving a diagnosis of endometrial hyperplasia.

Controls

Women in one large U.S. health care plan. Controls will consist of individually matched women who received a diagnosis of endometrial hyperplasia at the same age and date as the cases and were cancer-free and hysterectomy-free until the date at which the index cases were diagnosed with endometrial carcinoma or censored complex atypical hyperplasia.

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are conducting a nested case-control study of adenocarcinoma of the endometrium within a retrospective cohort of one large managed health care organization in the Northwest U.S. Cases, i.e., women who developed endometrial cancer after a diagnosis of endometrial hyperplasia, will be compared with women who were diagnosed with endometrial hyperplasia but did not develop cancer during an equivalent follow-up period, after controlling for relevant confounders.@@@@@@

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Kaiser Permanente Northwest

Hillsboro, Oregon, 97124, United States

Location

Related Publications (3)

• 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. doi: 10.1097/00004347-199701000-00006.

  PMID: 8986530 BACKGROUND

• Bergeron C, Nogales FF, Masseroli M, Abeler V, Duvillard P, Muller-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. doi: 10.1097/00000478-199909000-00014.

  PMID: 10478671 BACKGROUND

• Baak JP, Orbo 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. doi: 10.1097/00000478-200107000-00012.

  PMID: 11420465 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms; Uterine Hemorrhage; Hyperplasia; Disease Progression

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Nicolas Wentzensen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: November 25, 2002
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

US (1)