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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Mark Ellebaek Pedersen, Odense University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706809
First Posted: October 15, 2012
Last Update Posted: February 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, Odense University Hospital
  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

Further study details as provided by Mark Ellebaek Pedersen, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark Ellebaek Pedersen, Medical doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01706809     History of Changes
Other Study ID Numbers: S-20100006
First Submitted: October 11, 2012
First Posted: October 15, 2012
Last Update Posted: February 5, 2014
Last Verified: February 2014