Clinical trial · Observational
Biomarkers for Oral Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lichen Planus | — | UNRESOLVED | — |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oral Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Persons seen at dental clinics at 6 Veterans Affairs Medical Centers who had clinically visibleoral lesions
Primary outcomes (2)
- measure
- New or re-emergence of oral lesion
- timeFrame
- Annually
- description
- the natural history of the oral lesions was assessed via clinical examination over a period of 4 years
- measure
- oral cancer diagnosis
- timeFrame
- Once
- description
- Assessed via medical record
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Patients with white, red, or white and red lesions in the oral cavity and oropharynx as identified by the participating dentist.
References
Publications (3)
- BACKGROUNDBouquot JE, Gorlin RJ. Leukoplakia, lichen planus, and other oral keratoses in 23,616 white Americans over the age of 35 years. Oral Surg Oral Med Oral Pathol. 1986 Apr;61(4):373-81. doi: 10.1016/0030-4220(86)90422-6. PMID 3458148
- BACKGROUNDBrachman DG, Graves D, Vokes E, Beckett M, Haraf D, Montag A, Dunphy E, Mick R, Yandell D, Weichselbaum RR. Occurrence of p53 gene deletions and human papilloma virus infection in human head and neck cancer. Cancer Res. 1992 Sep 1;52(17):4832-6. PMID 1324797
- BACKGROUNDBrennan JA, Boyle JO, Koch WM, Goodman SN, Hruban RH, Eby YJ, Couch MJ, Forastiere AA, Sidransky D. Association between cigarette smoking and mutation of the p53 gene in squamous-cell carcinoma of the head and neck. N Engl J Med. 1995 Mar 16;332(11):712-7. doi: 10.1056/NEJM199503163321104. PMID 7854378