Sentinel Node in Colon Cancer | NCT00411112

Studies
Sentinel Node in Colon Cancer

NCT00411112

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 12, 2009Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

blue and isotopic detection of sentinel lymph nodes

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2013Estimated

Completion Date

Not provided

First Submitted Date

Dec 12, 2006

First Submission Date that Met QC Criteria

Dec 12, 2006

First Posted Date

Dec 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Name	Type	Description	Arm Group Labels	Other Names
blue and isotopic detection of sentinel lymph nodes	Procedure

Measure	Description	Time Frame
Survival without recurrence after 3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult
colon cancer
open surgery

Exclusion Criteria:

emergency surgery
metastases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cécile Brigand, MD	Contact	3 33 88 12 72 36		cecile.brigand@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Cécile Brigand, MD	Hôpitaux Universitaires de Strasbourg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre	Recruiting	Strasbourg		67098	France

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C027982	RID

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided