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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
University of Sheffield
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 25, 2007
    Last Updated
    December 17, 2013
    Sponsor
    University of Sheffield
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    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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