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Sentinel Node in Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00411112
First received: December 12, 2006
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sentinel Node Study in Colon Cancer Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00411112     History of Changes
Other Study ID Numbers: 3737
Study First Received: December 12, 2006
Last Updated: January 9, 2009
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013