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Sentinel Node in Colon 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 January 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411112
First Posted: December 13, 2006
Last Update Posted: January 12, 2009
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:
University Hospital, Strasbourg, France
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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
Criteria

Inclusion Criteria:

  • adult
  • colon cancer
  • open surgery

Exclusion Criteria:

  • emergency surgery
  • metastases
  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): 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

ClinicalTrials.gov Identifier: NCT00411112     History of Changes
Other Study ID Numbers: 3737
First Submitted: December 12, 2006
First Posted: December 13, 2006
Last Update Posted: January 12, 2009
Last Verified: January 2009

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