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
About this trial
This is an interventional treatment trial for Colon Cancer
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
Sites / Locations
- Legacy Good Samaritan Hospital and Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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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