Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Genetic: polymorphism analysis; Other: laboratory biomarker analysis; Genetic: mutation analysis; Other: questionnaire administration; Genetic: microarray analysis; Genetic: polymerase chain reaction

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 Type: Observational
• Enrollment (Anticipated): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival
Progressive disease-free survival

Collaborators and Investigators

• Sponsor: University of Sheffield
• Investigators: Study Chair: Angela Cox, PhD, University of Sheffield

Study record dates

Study Major Dates

• Study Start: July 1, 2002

Study Registration Dates

• First Submitted: April 25, 2007
• First Submitted That Met QC Criteria: April 25, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000540670; SHEFF-SSREC01/271; SHEFF-USMS-SSREC01/271; EU-20727