Sentinel Node in Colon Cancer

This study is currently recruiting participants.

Verified by University Hospital, Strasbourg, France, January 2009

First Received: December 12, 2006 Last Updated: January 9, 2009 History of Changes

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 Surgery

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

No publications provided

Study ID Numbers:	3737
Study First Received:	December 12, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00411112 History of Changes
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
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009