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

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ClinicalTrials.gov Identifier: NCT00899210
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Cancer Other: laboratory biomarker analysis Procedure: cryosurgery Procedure: radiofrequency ablation Procedure: therapeutic conventional surgery

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.


Study Type : Observational
Estimated Enrollment : 75 participants
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 Start Date : September 2003
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)

Secondary Outcome Measures :
  1. Predictive value of postoperative risk of recurrence
  2. Correlation of risk of recurrence with surgical technique
  3. Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence
  4. Correlation of postoperative serum HGF/SF with plasma levels in MMPs


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899210


Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Study Chair: Christine Rebischung University Hospital, Grenoble

ClinicalTrials.gov Identifier: NCT00899210     History of Changes
Other Study ID Numbers: CDR0000574192
CHUG-METALLO-1
RECF0455
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011

Keywords provided by National Cancer Institute (NCI):
liver metastases
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes