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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01484769
First received: November 30, 2011
Last updated: April 4, 2012
Last verified: June 2011
  Purpose

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
Squamous Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Further study details as provided by University of Louisville:

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.


Estimated Enrollment: 100
Study Start Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484769

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Wolfgang Zacharias, Ph.D.    502-852-2579    wolfgang.zacharias@louisville.edu   
Principal Investigator: Wolfgang Zacharias, Ph.D.         
Norton Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Wolfgang Zacharias, Ph.D.    502-852-2579    wolfgang.zacharias@louisville.edu   
Kosair Children's Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01484769     History of Changes
Other Study ID Numbers: 360.05
Study First Received: November 30, 2011
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014