Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
microarray analysis
mutation analysis
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic colorectal cancer
- Currently receiving chemotherapy at Weston Park Hospital
PATIENT CHARACTERISTICS:
- Not Specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Sites / Locations
Outcomes
Primary Outcome Measures
Survival
Progressive disease-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00467129
First Posted
April 25, 2007
Last Updated
December 17, 2013
Sponsor
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT00467129
Brief Title
Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
Official Title
The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
Study Type
Observational
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sheffield
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer
7. Study Design
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Survival
Title
Progressive disease-free survival
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of metastatic colorectal cancer
Currently receiving chemotherapy at Weston Park Hospital
PATIENT CHARACTERISTICS:
Not Specified
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Cox, PhD
Organizational Affiliation
University of Sheffield
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
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