Surgical Resection Lowers Oxidative Stress Markers in Pat... | NCT01470586

Studies
Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

NCT01470586

Sponsor

G. Hatzikosta General Hospital

Status

Completed

Last Update Posted

Nov 11, 2011Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Colorectal Cancer
Colon Rectal Resection
Oxidative Stress

Interventions

Surgery for colorectal cancer

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 5, 2011

First Submission Date that Met QC Criteria

Nov 10, 2011

First Posted Date

Nov 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2011

Last Update Posted Date

Nov 11, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

E.Tsimoyiannis, Head of Department of Surgery, G.Hatzikosta General Hospital, G. Hatzikosta General HospitalPrincipal Investigator

Lead Sponsor

G. Hatzikosta General HospitalOTHER

Collaborators

Name	Class
University of Ioannina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery for colorectal cancer	Other	Colorectal cancer patients	Procedure: Surgery for colorectal cancer
Controls	No Intervention	Controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery for colorectal cancer	Procedure	Surgical resection of colorectal cancer	Surgery for colorectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of Oxidative stress markers in patients with colorectal cancer and controls	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 Outcomes

Measure	Description	Time Frame
Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection	Validation of the responsiveness of markers of oxidative stress 8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery	up to 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Pappas-Gogos, MD	G. Hatzikosta General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
G. Hatzikosta General Hospital		Ioannina	Epirus	45001	Greece

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided