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Sentinel Node in Colon Cancer

This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, February 2008

Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00411112
  Purpose

More than 20% of patients operated on for colon cancer without node metastasis will develop visceral metastases. The purpose of the study is to determine sentinel lymph nodes with two methods: blue injection and isotopic detection. Sentinel nodes will then be analyzed by immunohistochemy to detect micrometastases. No adjuvant therapy will be proposed to the patient if there are only node's micrometastases and survival will be analyzed in regard to the presence of these micrometastasis.


Condition Intervention
Colon Cancer
Procedure: blue and isotopic detection of sentinel lymph nodes

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Iso-sulfan blue   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Sentinel Node Study in Colon Cancer Surgery

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Survival without recurrence after 3 years

Estimated Enrollment:   140
Study Start Date:   March 2007
Estimated Primary Completion Date:   March 2013 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • adult
  • colon cancer
  • open surgery

Exclusion Criteria:

  • emergency surgery
  • metastases
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411112

Contacts
Contact: Cécile Brigand, MD     3 33 88 12 72 36     cecile.brigand@chru-strasbourg.fr    

Locations
France
Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre     Recruiting
      Strasbourg, France, 67098
      Contact: Cécile Brigand, MD     33.3.88.12.72.36     cecile.brigand@chru-strasbourg.fr    
      Sub-Investigator: Christian Meyer, MD            
      Sub-Investigator: Serge Rohr, MD            
      Principal Investigator: Cécile Brigand, MD            

Sponsors and Collaborators
University Hospital, Strasbourg, France

Investigators
Study Director:     Cécile Brigand, MD     Hôpitaux Universitaires de Strasbourg    
  More Information


Study ID Numbers:   3737
First Received:   December 12, 2006
Last Updated:   February 22, 2008
ClinicalTrials.gov Identifier:   NCT00411112
Health Authority:   France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Sentinel node  
Isosulphan blue  
Isotopic detection  
Survival  

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008




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