NCT Number: NCT00899210
Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver 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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cryosurgery
ProcedureRadiofrequency ablation
Proceduretherapeutic conventional surgery
ProcedurePrimary outcomes
-
Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University Hospital, Grenoble
Other
Registry information
Official study 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
Important dates
- Study start
- 2003
- Primary completion
- 2011
- First posted
- May 12, 2009
- Registry last updated
- May 17, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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