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NCT01484769 Clinical Trial

Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Squamous Cell Carcinoma Clinical Trial

— H&N  

Official title:
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01484769
Other study ID # 360.05
Secondary ID
Status Withdrawn
Phase N/A
First received November 30, 2011
Last updated April 7, 2017
Start date July 2005
Est. completion date June 2012

Study information
Verified date April 2017
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Collection of tissues for analysis from patients undergoing elective neck dissection.

The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.

Description:

The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.

The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2012
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 7 Years and older
Eligibility Inclusion Criteria:

- All patients with biochemical evidence of squamous cell carcinoma of the head and neck.

Exclusion Criteria:

- Patients without biomedical evidence of squamous cell carcinoma.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Kosair Children's Hospital Louisville Kentucky
United States Norton Hospital Louisville Kentucky
United States University of Louisville Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

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