- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470586
Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
November 10, 2011 updated by: E.Tsimoyiannis, G. Hatzikosta General Hospital
Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Epirus
-
Ioannina, Epirus, Greece, 45001
- G. Hatzikosta General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with colorectal cancer
- Controls
Exclusion Criteria:
- ASA>3
- Metastatic Disease
- Acute bowel obstruction
- Acute bowel perforation
- BMI<30
- Chronic Systemic or Autoimmune Diseases
- Smokers
- Alcohol consumers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Surgery for colorectal cancer
Colorectal cancer patients
|
Surgical resection of colorectal cancer
Other Names:
|
No Intervention: Controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Oxidative stress markers in patients with colorectal cancer and controls
Time Frame: up to 2 years
|
Oxidative stress markers variation (8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG) during and after surgery for colorectal cancer, and compare with controls
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection
Time Frame: up to 2 years
|
Validation of the responsiveness of markers of oxidative stress 8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: George Pappas-Gogos, MD, G. Hatzikosta General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
November 5, 2011
First Submitted That Met QC Criteria
November 10, 2011
First Posted (Estimate)
November 11, 2011
Study Record Updates
Last Update Posted (Estimate)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH-1948-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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