- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706809
Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer
February 4, 2014 updated by: Mark Ellebaek Pedersen, Odense University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Anticipated)
30
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
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-
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Vejle, Denmark, 5000
- Recruiting
- Vejle Hospital
-
Contact:
- Hans Rahr, MD
- Phone Number: 0045 7940 5600
- Email: hans.rahr@slb.regionsyddanmark.dk
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing open LAR for rectum cancer is subjected.
Description
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
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Biomarkeres
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
after the study is complete
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2011
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
October 11, 2012
First Submitted That Met QC Criteria
October 12, 2012
First Posted (Estimate)
October 15, 2012
Study Record Updates
Last Update Posted (Estimate)
February 5, 2014
Last Update Submitted That Met QC Criteria
February 4, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20100006
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.