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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Metastatic Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery; Procedure: radiofrequency ablation; Procedure: cryosurgery

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
• Enrollment (Anticipated): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Study Chair: Christine Rebischung, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 14, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; liver metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CDR0000574192; CHUG-METALLO-1; RECF0455