Colorectal CancerNCT00899210
Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer
An observational study of Colorectal Cancer and Metastatic Cancer, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- laboratory biomarker analysis, cryosurgery and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- laboratory biomarker analysis, cryosurgery, radiofrequency ablation, therapeutic conventional surgery
- 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
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
cryosurgeryProcedure or surgery
radiofrequency ablationProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2003
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Christine Rebischung, Study chair, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899210
- Sponsor's protocol ID
- CDR0000574192
- Other IDs
- CHUG-METALLO-1, RECF0455
- Status last verified
- May 2011
- First submitted
- 9 May 2009
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00899210
- Acronym / sponsor ID
- CDR0000574192
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- May 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| cryosurgery | Procedure or surgery | – |
| radiofrequency ablation | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP)
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Rebischung study chair
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Metastatic Cancer, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of postoperative changes of serum matrix metalloproteinases (MMP) and their inhibitors (TIMP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.