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This study has been withdrawn prior to enrollment.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
  Purpose

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
Precancerous Conditions
Leukoplakia
Erythroplasia
Oral Papillomas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Oral Cancer Precursors

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Biospecimen Retention:   Samples With DNA

Oral brush samples.


Estimated Enrollment: 40
Study Start Date: November 2004
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care Dental and Otolaryngology clinics.

Criteria

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
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: NCT00179361

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Nicolas F Schlecht, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Nicolas F Schlecht, PhD, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00179361     History of Changes
Other Study ID Numbers: 2003 -434 -000, DE016089-01
Study First Received: September 13, 2005
Last Updated: November 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Precancerous Conditions
Leukoplakia
Erythroplasia
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014