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NCT00411112 Clinical Trial

Sentinel Node in Colon Cancer

Colon Cancer Clinical Trial

Official title:
Sentinel Node Study in Colon Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00411112
Other study ID # 3737
Secondary ID
Status Recruiting
Phase N/A
First received December 12, 2006
Last updated January 9, 2009
Start date March 2007

Study information
Verified date January 2009
Source University Hospital, Strasbourg, France
Contact Cécile Brigand, MD
Phone 3 33 88 12 72 36
Email cecile.brigand@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult

- colon cancer

- open surgery

Exclusion Criteria:

- emergency surgery

- metastases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• blue and isotopic detection of sentinel lymph nodes

Locations
Country Name City State
France Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival without recurrence after 3 years
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