Natural History of Oro-pharyngeal Cancer Precursors

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00179361
Study type	Observational
Source	Albert Einstein College of Medicine, Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 2004
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05215860` - Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates	N/A
Completed	`NCT04153266` - Oral Epithelial Dysplasia Informational Needs Questionnaire
Completed	`NCT01752114` - Early Diagnosis of Pulmonary Nodules	N/A
Completed	`NCT01752101` - Identification of a Plasma Proteomic Signature for Lung Cancer	N/A
Completed	`NCT00314262` - Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor	Phase 1/Phase 2
Completed	`NCT00036283` - Chemoprevention of Oral Premalignant Lesions	Phase 2
Recruiting	`NCT06165614` - Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya	Phase 1
Not yet recruiting	`NCT01837693` - Cervical Cancer Prevention: From DNA to mRNA? - New Technologies for Cervical Cancer Screening 2	N/A
Completed	`NCT00043615` - Collection of Blood, Bone Marrow, Tumor or Tissue Samples	N/A
Active, not recruiting	`NCT02158858` - A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis	Phase 1/Phase 2
Completed	`NCT02323672` - Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions	N/A
Completed	`NCT00851305` - Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy	N/A
Not yet recruiting	`NCT04065737` - Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization	Phase 2
Active, not recruiting	`NCT00655421` - Oral Cancer Screening in Mumbai, India by Primary Health Care Workers	Phase 3
Completed	`NCT00213603` - Follow-up Modalities of Low Grade Precancerous Bronchial Lesions	N/A
Completed	`NCT03100045` - Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)	Phase 1