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

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer

• Registration Number: NCT00899210
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-14
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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