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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899210
• Other study ID #: CDR0000574192
• Secondary ID: CHUG-METALLO-1RE
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 14, 2011
• Start date: September 2003

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• laboratory biomarker analysis

Procedure:
• cryosurgery

• radiofrequency ablation

• therapeutic conventional surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)			No
Secondary	Predictive value of postoperative risk of recurrence			No
Secondary	Correlation of risk of recurrence with surgical technique			No
Secondary	Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence			No
Secondary	Correlation of postoperative serum HGF/SF with plasma levels in MMPs			No