The Significance of Sentinel Node Analysis in Colon Cancer | NCT00419978

Studies
The Significance of Sentinel Node Analysis in Colon Cancer

NCT00419978

Sponsor

Legacy Health System

Status

Terminated

Last Update Posted

Jul 4, 2008Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

Colectomy

Countries

United States

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrural to study.

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Jan 5, 2007

First Submission Date that Met QC Criteria

Jan 5, 2007

First Posted Date

Jan 9, 2007Estimated

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

Jun 27, 2008

Last Update Posted Date

Jul 4, 2008Estimated

Description Module

Brief Summary

This study is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. The sentinel node is the one located closest to your tumor. This study will find out if examining the sentinel node can help to predict disease progression. Since the value of this exam is unknown, taking part in this study will not change your clinical care.

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

24Actual

Name	Type	Description	Arm Group Labels	Other Names
Colectomy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients must consent to participate in study
Patients will be tracked for five years
A blood test (CEA) will be collected every six months
A CT scan will be performed annually
A colonoscopy will be performed at 1 and 5 years post-surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Whiteford, MD	Legayc Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Legacy Good Samaritan Hospital and Medical Center		Portland	Oregon	97210	United States

Label	URL
Legacy's internet website	View source

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
D003082	Colectomy

Ancestor Terms

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided