Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014079
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2001-04-10
Brief Title:
Genetic Markers in Patients With Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Clinical Significance of Genetic Markers in Colon 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 Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse
PURPOSE This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer
PURPOSE This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer
Detailed Description:
OBJECTIVES
Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer tumor microsatellite instability
Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5 8 17 and 18 as the primary targets and of chromosomes 1 14 and 22 as the secondary targets in colorectal cancer
OUTLINE DNA is examined for unstable elements microsatellite instability and loss of heterozygosity by analyzing at least 10 separate CAn-repeats localized to 5 separate chromosomes 5q 8p 15 17p and 18q Loss of heterozygosity is analyzed for at least four chromosomal arms 5q 8p 17p and 18q and later other chromosomes eg 1 14 and 22 Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair hMLH1 and hMSH2
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL This study will accrue up to 708 specimens
Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer tumor microsatellite instability
Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5 8 17 and 18 as the primary targets and of chromosomes 1 14 and 22 as the secondary targets in colorectal cancer
OUTLINE DNA is examined for unstable elements microsatellite instability and loss of heterozygosity by analyzing at least 10 separate CAn-repeats localized to 5 separate chromosomes 5q 8p 15 17p and 18q Loss of heterozygosity is analyzed for at least four chromosomal arms 5q 8p 17p and 18q and later other chromosomes eg 1 14 and 22 Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair hMLH1 and hMSH2
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL This study will accrue up to 708 specimens
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 |
|---|---|---|---|
| CDR0000065549 | REGISTRY | PDQ Physician Data Query | None |