Viewing Study NCT00467129



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Last Modification Date: 2024-10-26 @ 9:32 AM
Study NCT ID: NCT00467129
Status: UNKNOWN
Last Update Posted: 2013-12-18
First Post: 2007-04-25

Brief Title: Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
Sponsor: University of Sheffield
Organization: National Cancer Institute NCI

Study Overview

Official Title: The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
Status: UNKNOWN
Status Verified Date: 2007-05
Last Known Status: ACTIVE_NOT_RECRUITING
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 Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment

PURPOSE This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer
Detailed Description: OBJECTIVES

Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer
Collect detailed clinical pathological and chemotherapy data from these patients
Identify genetic factors that relate to treatment response and outcome in these patients

OUTLINE Blood samples are collected and relevant genes and regions are amplified by PCR PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes

Clinical and family history data is also collected by questionnaire

PROJECTED ACCRUAL A total of 800 patients will be accrued for this study

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
EU-20727 None None None
SHEFF-SSREC01271 None None None
SHEFF-USMS-SSREC01271 None None None