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Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells (H&N)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484769
First Posted: December 2, 2011
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Louisville
November 30, 2011
December 2, 2011
April 10, 2017
July 2005
June 2011   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT01484769 on ClinicalTrials.gov Archive Site
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Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Tissue samples from patients undergoing elective neck dissection will be collected. Primary tumors and adjacent normal tissue from unaffected areas will be collected at the time of surgery. All tissue dissection and removal are part of the standard of care for this type of surgical procedure. Remaining resected tissue will be used for research.
Non-Probability Sample
Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.
Squamous Cell Carcinoma
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01484769
360.05
No
Not Provided
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University of Louisville
University of Louisville
Not Provided
Not Provided
University of Louisville
April 2017