Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339651
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2006-06-19
Brief Title:
Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define an Optimal Classification of Endometrial Carcinoma Precursors
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Three systems have been proposed to classify endometrial carcinoma precursors but it is currently unclear which system best predicts cancer risk and is most reproducible The optimal surrogate endpoint for endometrial carcinoma is therefore unknown The pathologic diagnosis of endometrial hyperplasia EH includes most suspected immediate precursors and many mild highly reversible proliferations We propose an exploratory study to assess the feasibility of investigating EH as a source of an endometrial carcinoma surrogate endpoint
We are conducting a nested case-control study within a large population-based health care plan We will identify cases defined as women who were diagnosed with EH at least one year before being diagnosed with endometrial carcinoma or severe atypical hyperplasia at hysterectomy through a computerized search of plan databases We will retrieve the slides from the matching biopsy and hysterectomy on which carcinoma was diagnosed Women ages 40 or older who were plan members and received a biopsy or curettage diagnosis of EH between 1970 and 2002 will be eligible to be a case
We will perform an initial histologic review of cases index biopsy slides to assess two types of misclassification known to affect the diagnosis of EH a false-negative endometrial carcinoma ie prevalent carcinoma t the time of EH diagnosis and b false-positive EH ie a benign non-hyperplastic lesion From cases physical records and linked computer records we will collect data on histopathologic classification of EH lesions and subsequent carcinomas descriptive data eg patient weight parity and menopausal status and a summary of relevant treatments and follow-up procedures eg hormone therapy or additional clinical procedures
We will select controls defined as women who were diagnosed with EH but then did not develop endometrial carcinoma or undergo hysterectomy for a follow-up interval that is equivalent to the follow-up interval of the cases Controls will be individually matched to cases on age at EH diagnosis date of EH diagnosis and duration of follow-up and also counter-matched based on the original EH diagnosis After selecting 3 controls per case we will assemble the same data from controls histologic review of original slides descriptive data from medical records databases and treatment and follow-up procedure data from linked databases
These data will then be used to estimate the cancer risk associated with specific EH classifications identify other patient or clinical factors that might modify those risks explore predictors of EH and explore molecular factors that might influence the probability of developing carcinoma after a diagnosis of EH
We are conducting a nested case-control study within a large population-based health care plan We will identify cases defined as women who were diagnosed with EH at least one year before being diagnosed with endometrial carcinoma or severe atypical hyperplasia at hysterectomy through a computerized search of plan databases We will retrieve the slides from the matching biopsy and hysterectomy on which carcinoma was diagnosed Women ages 40 or older who were plan members and received a biopsy or curettage diagnosis of EH between 1970 and 2002 will be eligible to be a case
We will perform an initial histologic review of cases index biopsy slides to assess two types of misclassification known to affect the diagnosis of EH a false-negative endometrial carcinoma ie prevalent carcinoma t the time of EH diagnosis and b false-positive EH ie a benign non-hyperplastic lesion From cases physical records and linked computer records we will collect data on histopathologic classification of EH lesions and subsequent carcinomas descriptive data eg patient weight parity and menopausal status and a summary of relevant treatments and follow-up procedures eg hormone therapy or additional clinical procedures
We will select controls defined as women who were diagnosed with EH but then did not develop endometrial carcinoma or undergo hysterectomy for a follow-up interval that is equivalent to the follow-up interval of the cases Controls will be individually matched to cases on age at EH diagnosis date of EH diagnosis and duration of follow-up and also counter-matched based on the original EH diagnosis After selecting 3 controls per case we will assemble the same data from controls histologic review of original slides descriptive data from medical records databases and treatment and follow-up procedure data from linked databases
These data will then be used to estimate the cancer risk associated with specific EH classifications identify other patient or clinical factors that might modify those risks explore predictors of EH and explore molecular factors that might influence the probability of developing carcinoma after a diagnosis of EH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N053 | None | None | None |