Natural History of Oro-pharyngeal Cancer Precursors

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00179361
• Collaborator: (none)
• Enrollment: 374
• Location: 1
• Duration (Months): 115.9
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Precancerous Conditions; Leukoplakia; Erythroplasia; Oral Papillomas

Study Design

• Study Type: Observational
• Actual Enrollment: 374 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural History of Oral Cancer Precursors
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Albert Einstein College of Medicine

Investigators

• Principal Investigator: Nicolas F Schlecht, PhD, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicolas Schlecht, PhD, Ass. Prof. Epidemiology & Population Health, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT00179361
• Other Study ID Numbers: 2003-434; DE016089-01
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 2, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Papilloma; Precancerous Conditions; Leukoplakia; Erythroplasia

Study Results

No Results Posted as of Mar 2, 2018