Back to results

Sentinel Node in Colon Cancer

Primary Purpose

Colon Cancer

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blue and isotopic detection of sentinel lymph nodes

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Sentinel node, Isosulphan blue, Isotopic detection, Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult
colon cancer
open surgery

Exclusion Criteria:

emergency surgery
metastases

Sites / Locations

Service de Chirurgie Générale et Digestive - Hôpital de HautepierreRecruiting

Outcomes

Primary Outcome Measures

Survival without recurrence after 3 years

Secondary Outcome Measures

Full Information

NCT ID

NCT00411112

First Posted

December 12, 2006

Last Updated

January 9, 2009

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00411112

Brief Title

Sentinel Node in Colon Cancer

Official Title

Sentinel Node Study in Colon Cancer Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

Sentinel node, Isosulphan blue, Isotopic detection, Survival

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

blue and isotopic detection of sentinel lymph nodes

Primary Outcome Measure Information:

Title

Survival without recurrence after 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult colon cancer open surgery Exclusion Criteria: emergency surgery metastases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cécile Brigand, MD

Phone

3 33 88 12 72 36

cecile.brigand@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cécile Brigand, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cécile Brigand, MD

Phone

33.3.88.12.72.36

cecile.brigand@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Christian Meyer, MD

First Name & Middle Initial & Last Name & Degree

Serge Rohr, MD

First Name & Middle Initial & Last Name & Degree

Cécile Brigand, MD

12. IPD Sharing Statement

Learn more about this trial

Sentinel Node in Colon Cancer

We'll reach out to this number within 24 hrs