Biomarkers for Oral Cancer
Key facts
- Who runs it
- National Cancer Institute (NCI)
- Where
- Atlanta, Danville, Durham, San Antonio, San Francisco, and Washington D.C., United StatesSee the 6 sites
- Trial code
- Status
- Completed
- People taking part
- 80 people enrolled
- Started
- 28 Aug 1996
- Ended
- 29 Jul 2025
- Type of study
- Observational
- Record updated
- 31 July 2025
Who can take part
- Age
- 18 years to 110 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show the criterionShow less
Other criteria
- INCLUSION CRITERIA:; Patients with white, red, or white and red lesions in the oral cavity and oropharynx as identified by the participating dentist
Where in United States
- VA Medical Ctr, AtlantaAtlanta, United States
- Veterans Affairs, DanvilleDanville, United States
- VA Medical Center - DurhamDurham, United States
- Veterans Affairs, San AntonioSan Antonio, United States
- U.C.S.F./ Vterans Affairs Medical CenterSan Francisco, United States
- VA Medical Center, Washington D.C.Washington D.C., United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 information about sociodemograhic, medical, and lifestyle factors, particularly tobacco and alcohol use all as part of the study protocol, and the patient received a biopsy as part of 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.
This study is particularly valuable because longitudinal data was collected and because the data were collected over time using standard procedures.
The group in the trial
- Cohort
Persons seen at dental clinics at 6 Veterans Affairs Medical Centers who had clinically visibleoral lesions
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 31 July 2025