Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044967
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2002-09-06
Brief Title:
Genetic Study of Young Patients With Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Identifying gene mutations microsatellite instability may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age
PURPOSE Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I stage II or stage III colorectal cancer at an early age
PURPOSE Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I stage II or stage III colorectal cancer at an early age
Detailed Description:
OBJECTIVES
Evaluate the prognostic significance eg overall survival of microsatellite instability MSI status in patients with early age-of-onset stage I-III colorectal cancer assuming the presence of a quantitative interaction between MSI status and family history of cancer
Evaluate the development of metachronous neoplasms in this patient population
Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population
OUTLINE This is a multicenter study Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer positive vs negative
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1 3 and 5 years - 6 months after resection The number size location histology and method of removal of polyps are documented at the time of colonoscopy Patients also undergo microsatellite instability MSI status testing and complete family history questionnaires at baseline
The prognostic significance of family history and MSI status is evaluated The individual histologic features of the tumors are compared with the MSI status to determine their predictive value The histologic features are also correlated with outcome to determine their prognostic significance
Patients may be referred for genetic counseling
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute
Evaluate the prognostic significance eg overall survival of microsatellite instability MSI status in patients with early age-of-onset stage I-III colorectal cancer assuming the presence of a quantitative interaction between MSI status and family history of cancer
Evaluate the development of metachronous neoplasms in this patient population
Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population
OUTLINE This is a multicenter study Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer positive vs negative
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1 3 and 5 years - 6 months after resection The number size location histology and method of removal of polyps are documented at the time of colonoscopy Patients also undergo microsatellite instability MSI status testing and complete family history questionnaires at baseline
The prognostic significance of family history and MSI status is evaluated The individual histologic features of the tumors are compared with the MSI status to determine their predictive value The histologic features are also correlated with outcome to determine their prognostic significance
Patients may be referred for genetic counseling
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute
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 |
|---|---|---|---|
| CDR0000069465 | REGISTRY | NCI Physician Data Query | None |
| ACOSOG-Z0190 | None | None | None |