NCT01470586

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

November 5, 2011

Last Update Submit

November 10, 2011

Conditions

Colorectal CancerColon Rectal ResectionOxidative Stress

Keywords

Colorectal cancerSurgical resectionOxidative Stress MarkersControls

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection

    up to 2 years

Study Arms (2)

Surgery for colorectal cancer

OTHER

Colorectal cancer patients

Procedure: Surgery for colorectal cancer

Controls

NO INTERVENTION

Controls

Interventions

Surgery for colorectal cancerPROCEDURE

Surgical resection of colorectal cancer

Also known as: Open or Laparoscopic resection for colorectal cancer, Low anterior resection, Sigmoidectomy, Left colectomy, Trasverse colectomy, Right colectomy
Surgery for colorectal cancer

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with colorectal cancer
  • Controls

You may not qualify if:

  • ASA\>3
  • Metastatic Disease
  • Acute bowel obstruction
  • Acute bowel perforation
  • BMI\<30
  • Chronic Systemic or Autoimmune Diseases
  • Smokers
  • Alcohol consumers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. Hatzikosta General Hospital

Ioannina, Epirus, 45001, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • George Pappas-Gogos, MD

    G. Hatzikosta General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Surgery, G.Hatzikosta General Hospital

Study Record Dates

First Submitted

November 5, 2011

First Posted

November 11, 2011

Study Start

May 1, 2009

Primary Completion

October 1, 2010

Study Completion

June 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

GR(1)