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The Significance of Sentinel Node Analysis in Colon Cancer

Primary Purpose

Colon Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colectomy
Sponsored by
Legacy Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Legacy Good Samaritan Hospital and Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 5, 2007
Last Updated
June 27, 2008
Sponsor
Legacy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00419978
Brief Title
The Significance of Sentinel Node Analysis in Colon Cancer
Official Title
The Significance of Sentinel Node Analysis in Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Slow accrural to study.
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Legacy Health System

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Colectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Whiteford, MD
Organizational Affiliation
Legayc Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Good Samaritan Hospital and Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.legacyhealth.org
Description
Legacy's internet website

Learn more about this trial

The Significance of Sentinel Node Analysis in Colon Cancer

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