Trial Information

Biomarkers for Oral Cancer

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 at each of these visits so that lifestyle factors such as tobacco
and alcohol use could be reassessed. Also, oral epithelial cell scrapings were obtained at
each of these visits.

Analysis is focusing on the loss of heterozygosity and microsatellite instability as
indicators of genetic damage and the relationship of damage to smoking and genotypes as well
as how well findings from the oral rinses and brushes correspond to those in lesion tissues.