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NCT00467129 Clinical Trial

Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00467129
Other study ID # CDR0000540670
Secondary ID SHEFF-SSREC01/27
Status Active, not recruiting
Phase N/A
First received April 25, 2007
Last updated December 17, 2013
Start date July 2002

Study information
Verified date May 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 800
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of metastatic colorectal cancer

- Currently receiving chemotherapy at Weston Park Hospital

PATIENT CHARACTERISTICS:

- Not Specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Genetic:
• microarray analysis

• mutation analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

• questionnaire administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Sheffield

Outcome
Type Measure Description Time frame Safety issue
Primary Survival No
Primary Progressive disease-free survival No
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