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NCT01623258 Clinical Trial

A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma

Colon Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01623258
Other study ID # 03-20010
Secondary ID
Status Completed
Phase N/A
First received June 15, 2012
Last updated June 18, 2012
Start date December 2002
Est. completion date August 2011

Study information
Verified date June 2012
Source Walter Reed Army Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.

Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. 18 years of age

2. Primary, non-metastatic [Stage I, II (localized, node negative), or III (localized, node positive)] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology

3. Palpable mass at time of surgery

4. Capable of providing informed consent

Exclusion Criteria:

1. Prior radiation or chemotherapy

2. Non-palpable colon tumor

3. Recurrent or Stage IV (metastatic) colon cancer

4. Unable to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Walter Reed Army Medical Center Washington DC District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping 1 day No
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