NCT00899210

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

7.7 years

First QC Date

May 9, 2009

Last Update Submit

May 14, 2011

Conditions

Keywords

liver metastasesadenocarcinoma of the colonstage IV colon canceradenocarcinoma of the rectumstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)

Secondary Outcomes (4)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

CryosurgeryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeRadiofrequency TherapyTherapeutics

Study Officials

  • Christine Rebischung

    University Hospital, Grenoble

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

September 1, 2003

Primary Completion

May 1, 2011

Last Updated

May 17, 2011

Record last verified: 2011-05