Clinical Trial: Biomarkers for Oral Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Biomarkers for Oral Cancer

Brief Summary:

The purpose is to determine the extent of genetic damage in oral mucosal lesions ascertained in the study, whether specific genotypes are associated with genetic damage observed in the oral mucosal lesions, whether the extent of genetic damage changes over time, and what factors (e.g. smoking) contribute to those changes. Genetic damage indicators will include among others DNA adduct formation, particularly related to tobacco smoke carcinogens such as polycyclic aromatic hydocarbons. The genotypes of interest will be focused on these affecting carcinogen metabolism, (e.g., (CYP family), but may also include those related to growth factors, cell cycle control, and DNA repair. Microsatellite instability is another key indicator of damage that we plan to examine. This study was undertaken due to the paucity of data on the types of oral lesions seen in general dental practice and the limited knowledge of the natural history of these lesions.

Persons were enrolled who had red and/or white oral lesions identified at 6 Dental Clinics at VA Medical Centers. The VA Centers involved were: Washington, DC; Atlanta, GA; Durham, NC; San Francisco, CA; Danville, IL; and San Antonio, TX.

When a dentist found a red or white lesions in the course of routine outpatient examinations and care, obvious causes such as denture frictional lesions could be ruled out, and the normal standard of care for the lesion was biopsy, the patient was considered for enrollment into the study. The study was described to the patient, the consent for was signed, the patient received an intraoral examination to identify and characterize the oral lesions, the lesions were photographed, an oral epithelial cell sample was taken from the site and from the rest of the oral mucosa, and the patient was interviewed using a standard questionnaire that requested informatio

Detailed Summary:

The Biomarkers for Oral Cancer study was undertaken to better understand the role of genetic and lifestyle factors in the natural history of these oral premalignant lesions. The purpose of this study is to determine the extent of genetic damage in oral mucosal lesions ascertained in the study, whether specific genotypes are associated with genetic damage observed in the oral mucosal lesions, whether the extent of genetic damage changes over time, and what factors (e.g. smoking) contribute to those changes. This study is particularly valuable because longitudinal data was collected over time using standardized procedures.

Persons were enrolled in the study who had red and/or white oral lesions identified at 6 Dental Clinics at VA Medical Centers. When a dentist found a red or white lesion in the course of routine outpatient examinations and care, obvious causes such as denture frictional lesions could be ruled out, and when the normal standard of care for the lesion was biopsy, the patient was considered for enrollment into the study. The study was described to the patient, the consent form was signed, the patient received an intraoral examination to identify and characterize the oral lesions, the lesions were photographed, an oral epithelial cell sample was taken from the site and from the rest of the oral mucosa, and the patient was interviewed using a standard questionnaire that requested information about sociodemographic, medical, and lifestyle factors, particularly tobacco and alcohol use all as part of the study protocol. The patient s lesion was biopsied as part of his normal care. The biopsy report was obtained, as was a small piece of the biopsy material that was not needed for patient diagnostic purposes. The subjects returned every 4-6 months for reassessment of the lesion or to determine that the lesion had not returned. The patients completed a questionnaire
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Current Primary Outcome: New or re-emergence of oral lesion [ Time Frame: Annually ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 19, 2006
Date Started: August 28, 1996
Date Completion:
Last Updated: April 21, 2017
Last Verified: June 10, 2016