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Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
laboratory biomarker analysis
cryosurgery
radiofrequency ablation
therapeutic conventional surgery
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Colorectal Cancer focused on measuring liver metastases, adenocarcinoma of the colon, stage IV colon cancer, adenocarcinoma of the rectum, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Patients with histologically confirmed adenocarcinoma of the colon or rectum and liver metastases

      • Must have undergone prior complete resection of the tumor more than 3 months ago
      • Liver metastases must be resectable or accessible for radiofrequency ablation
    • Patients undergoing cryosurgery of the digestive tract for a reason other than cancer or infection (control)

PATIENT CHARACTERISTICS:

  • No other neoplastic disease that is measurable or being treated other than colorectal cancer
  • No heart failure or severe respiratory disease
  • No uncontrolled infection or other severe disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No participation in another study involving new drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)

    Secondary Outcome Measures

    Predictive value of postoperative risk of recurrence
    Correlation of risk of recurrence with surgical technique
    Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence
    Correlation of postoperative serum HGF/SF with plasma levels in MMPs

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    May 14, 2011
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00899210
    Brief Title
    Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer
    Official Title
    Study of Diagnostic Tests Studying Kinetic Variation of Serum Matrix Metalloproteases After Surgical Treatment and/or Destruction by Radiofrequency in Patients With Hepatic Metastases From Colorectal Cancer
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research trial is studying matrix metalloproteinases after surgery or radiofrequency ablation in patients with liver metastases from colorectal cancer.
    Detailed Description
    OBJECTIVES: Primary Describe the kinetics of postoperative changes of serum matrix metalloproteinases (MMP) (MMP-1, MMP-2, MMP-7, MMP-9) and their inhibitors (TIMP) (TIMP-1, TIMP-2) as a function of surgical technique. Secondary Determine the predictive value of postoperative risk of recurrence. Correlate the risk of recurrence with surgical technique. Determine whether elevated serum levels of MMP are a better marker than the carcinoembryonic antigen of hepatic or extrahepatic recurrence. Determine whether the postoperative serum of HGF/SF is correlated to changes in plasma levels of MMPs. OUTLINE: Blood samples are collected periodically before and after treatment to analyze for metalloproteinases and their inhibitors. After completion of study treatment, patients are followed at day 45 and then every 3 months for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Metastatic Cancer
    Keywords
    liver metastases, adenocarcinoma of the colon, stage IV colon cancer, adenocarcinoma of the rectum, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

    7. Study Design

    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Type
    Procedure
    Intervention Name(s)
    cryosurgery
    Intervention Type
    Procedure
    Intervention Name(s)
    radiofrequency ablation
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Primary Outcome Measure Information:
    Title
    Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)
    Secondary Outcome Measure Information:
    Title
    Predictive value of postoperative risk of recurrence
    Title
    Correlation of risk of recurrence with surgical technique
    Title
    Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence
    Title
    Correlation of postoperative serum HGF/SF with plasma levels in MMPs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Patients with histologically confirmed adenocarcinoma of the colon or rectum and liver metastases Must have undergone prior complete resection of the tumor more than 3 months ago Liver metastases must be resectable or accessible for radiofrequency ablation Patients undergoing cryosurgery of the digestive tract for a reason other than cancer or infection (control) PATIENT CHARACTERISTICS: No other neoplastic disease that is measurable or being treated other than colorectal cancer No heart failure or severe respiratory disease No uncontrolled infection or other severe disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No participation in another study involving new drugs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christine Rebischung
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer

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