Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer

This study is currently recruiting participants.
Verified February 2014 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01706809
First received: October 11, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.


Condition Intervention
Rectal Cancer
Other: blood sampels from vena rectalis superior and vena cubiti

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival. [ Time Frame: after the study is complete ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biomarkeres Other: blood sampels from vena rectalis superior and vena cubiti

Detailed Description:

Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected.

A total of 50 patients will be included in this study.

The study is approved by the local scientific ethical committee No. S-20100006

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing open LAR for rectum cancer is subjected.

Criteria

Inclusion Criteria:

  • Histological verified cancer
  • The cancer must be located in rectum maximum of 15 cm.
  • Age above 18

Exclusion Criteria:

  • Disseminated cancer
  • Perioperative radio-chemotherapy
  • Laparoscopy surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706809

Locations
Denmark
Vejle hospital Recruiting
Vejle, Denmark, 5000
Contact: Hans Rahr, MD    7940 5600 ext 0045    hans.rahr@slb.regionsyddanmark.dk   
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Mark Ellebaek Pedersen, Medical doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01706809     History of Changes
Other Study ID Numbers: S-20100006, S-20100006
Study First Received: October 11, 2012
Last Updated: February 4, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 14, 2014