We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01484769
Recruitment Status : Withdrawn
First Posted : December 2, 2011
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Brief 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.


Condition or disease
Squamous Cell Carcinoma

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
Study Start Date : July 2005
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2012



Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484769


Locations
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Norton Hospital
Louisville, Kentucky, United States, 40202
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01484769     History of Changes
Other Study ID Numbers: 360.05
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell