Sentinel Node in Colon Cancer

NCT ID: NCT00411112

Last Updated: 2009-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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blue and isotopic detection of sentinel lymph nodes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult
* colon cancer
* open surgery

Exclusion Criteria

* emergency surgery
* metastases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Principal Investigators

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Cécile Brigand, MD

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile Brigand, MD

Role: CONTACT

3 33 88 12 72 36

Facility Contacts

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Cécile Brigand, MD

Role: primary

33.3.88.12.72.36

Other Identifiers

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3737

Identifier Type: -

Identifier Source: org_study_id

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