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

Sponsored by:	CHU de Grenoble - Hopital Michallon
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899210

Purpose

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.

Condition	Intervention
Colorectal Cancer Metastatic Cancer	Other: laboratory biomarker analysis Procedure: cryosurgery Procedure: radiofrequency ablation Procedure: therapeutic conventional surgery

Study Type:	Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Predictive value of postoperative risk of recurrence [ Designated as safety issue: No ]
Correlation of risk of recurrence with surgical technique [ Designated as safety issue: No ]
Elevated serum levels of MMP vs carcinoembryonic antigen as a marker of hepatic or extrahepatic recurrence [ Designated as safety issue: No ]
Correlation of postoperative serum HGF/SF with plasma levels in MMPs [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	September 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899210

Sponsors and Collaborators

CHU de Grenoble - Hopital Michallon

Investigators

Study Chair:

Christine Rebischung

CHU de Grenoble - Hopital Michallon

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574192, CHUG-METALLO-1, RECF0455
Study First Received:	May 9, 2009
Last Updated:	May 16, 2009
ClinicalTrials.gov Identifier:	NCT00899210 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

liver metastases
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum

stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence

Intestinal Neoplasms
Rectal Cancer
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Neoplasms

Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009