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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899210
First received: May 9, 2009
Last updated: May 14, 2011
Last verified: May 2011
  Purpose

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 Intervention
Colorectal Cancer
Metastatic Cancer
Other: laboratory biomarker analysis
Procedure: cryosurgery
Procedure: radiofrequency ablation
Procedure: therapeutic conventional surgery

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictive value of postoperative risk of recurrence [ Designated as safety issue: No ]
  • Correlation of risk of recurrence with surgical technique [ Designated as safety issue: No ]
  • Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence [ Designated as safety issue: No ]
  • Correlation of postoperative serum HGF/SF with plasma levels in MMPs [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2003
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899210

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899210     History of Changes
Other Study ID Numbers: CDR0000574192, CHUG-METALLO-1, RECF0455
Study First Received: May 9, 2009
Last Updated: May 14, 2011
Health Authority: United States: Federal Government

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014