Clinical trial NCT00899210: Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Metastatic Cancer
Keywords: liver metastases
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
measure: Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)
Secondary outcomes:
measure: Predictive value of postoperative risk of recurrence
measure: Correlation of risk of recurrence with surgical technique
measure: Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence
measure: Correlation of postoperative serum HGF/SF with plasma levels in MMPs
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Christine Rebischung
role: STUDY_CHAIR
References: