Natural History of Oro-pharyngeal Cancer Precursors

This study has been withdrawn prior to enrollment.
(This study is not an applicable clinical trial.)
Sponsor:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179361
First received: September 13, 2005
Last updated: November 23, 2009
Last verified: November 2009

September 13, 2005
November 23, 2009
November 2004
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00179361 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Natural History of Oro-pharyngeal Cancer Precursors
Natural History of Oral Cancer Precursors

Oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques. Known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet and, in a subset of tumors, human papillomavirus (HPV). Along the oro-pharyngeal disease continuum, there may be variations in gene expression precursor lesions as a result of exposure to smoking, alcohol and HPV. However, the components of gene expression that are most likely associated with tumorigenesis in these tissues are poorly understood. This study will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects who have precursor lesions and have been exposed to the common risk factors for carcinoma development including smoking and HPV infection. This application is to conduct pilot testing and establish appropriate procedures for an international prospective cohort study of the natural history of oro-pharyngeal cancer precursors among men and women at high risk of oro-pharyngeal cancer at Montefiore Medical Center, Bronx-NY. Brush biopsy specimens will be used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as normal tissue from defined regions of the oral and pharyngeal mucosa. Measurement of gene expression will employ novel high-throughput cDNA microarray analysis and PCR-based HPV DNA testing. Oro-pharyngeal dysplasia will be diagnosed using cytopathology. Under this application, we will assess our planned instruments and procedures on an initial sample of 40 subjects. This planning period will allow for precise identification of methodologies, standardization of instruments and assays to be utilized by additional participating centers in a subsequent application.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Oral brush samples.

Non-Probability Sample

Primary care Dental and Otolaryngology clinics.

  • Precancerous Conditions
  • Leukoplakia
  • Erythroplasia
  • Oral Papillomas
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
Not Provided
Not Provided

Inclusion Criteria:

  • Established residence in the greater Metropolitan area of New York City, including Westchester, Long Island, Southern Connecticut and Northern New Jersey

Exclusion Criteria:

  • No history of therapy for oral cancer in the previous 6 months
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179361
2003 -434 -000, DE016089-01
No
Nicolas F Schlecht, PhD, Albert Einstein College of Medicine
Albert Einstein College of Medicine of Yeshiva University
Not Provided
Principal Investigator: Nicolas F Schlecht, PhD Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP