NCT00411112

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

6 years

First QC Date

December 12, 2006

Last Update Submit

January 9, 2009

Conditions

Colon Cancer

Keywords

Sentinel nodeIsosulphan blueIsotopic detectionSurvival

Outcome Measures

Primary Outcomes (1)

  • Survival without recurrence after 3 years

Interventions

blue and isotopic detection of sentinel lymph nodesPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • colon cancer
  • open surgery

You may not qualify if:

  • emergency surgery
  • metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

RID

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Cécile Brigand, MD

    Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Central Study Contacts

Cécile Brigand, MD

CONTACT

3 33 88 12 72 36cecile.brigand@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

March 1, 2007

Primary Completion

March 1, 2013

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

FR(1)