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Trial record 43 of 7419 for:    Oral Cancer | ( Map: United States )

Natural History of Oro-pharyngeal Cancer Precursors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00179361
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nicolas Schlecht, PhD, Albert Einstein College of Medicine

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 16, 2005
Last Update Posted Date March 2, 2018
Study Start Date November 2004
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Oro-pharyngeal Cancer Precursors
Official Title Natural History of Oral Cancer Precursors
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Oral brush samples.
Sampling Method Non-Probability Sample
Study Population Primary care Dental and Otolaryngology clinics.
Condition
  • Precancerous Conditions
  • Leukoplakia
  • Erythroplasia
  • Oral Papillomas
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Muller K, Kazimiroff J, Fatahzadeh M, Smith RV, Wiltz M, Polanco J, Grossberg RM, Belbin TJ, Strickler HD, Burk RD, Schlecht NF. Oral Human Papillomavirus Infection and Oral Lesions in HIV-Positive and HIV-Negative Dental Patients. J Infect Dis. 2015 Sep 1;212(5):760-8. doi: 10.1093/infdis/jiv080. Epub 2015 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2017)
374
Original Enrollment
 (submitted: September 13, 2005)
40
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00179361
Other Study ID Numbers 2003-434
DE016089-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nicolas Schlecht, PhD, Albert Einstein College of Medicine
Study Sponsor Albert Einstein College of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Nicolas F Schlecht, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date February 2018