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

April 7, 2017 updated by: University of Louisville

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.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Kosair Children's Hospital
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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