Biomarkers for Oral Cancer

NCT00341497 | Completed

• 2 other identifiers: 999998040OH98-D-N040
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 6

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 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

Lichen Planus; Oral Leukoplakia; Mouth Neoplasms

Keywords

Leukoplakia; Oral Mucosa; Biomarkers; Natural History

Outcome Measures

Primary Outcomes (2)

• New or re-emergence of oral lesion

  the natural history of the oral lesions was assessed via clinical examination over a period of 4 years

  Annually

• oral cancer diagnosis

  Assessed via medical record

  Once

Study Arms (1)

Cohort

Persons seen at dental clinics at 6 Veterans Affairs Medical Centers who had clinically visibleoral lesions

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons seen at dental clinics at 6 Veterans Affairs Medical Centers who had clinically visible oral lesions@@@

You may qualify if:

• Patients with white, red, or white and red lesions in the oral cavity and oropharynx as identified by the participating dentist.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (6)

U.C.S.F./ Vterans Affairs Medical Center

San Francisco, California, 94143, United States

Location

VA Medical Center, Washington D.C.

Washington D.C., District of Columbia, 20422, United States

Location

VA Medical Ctr, Atlanta

Atlanta, Georgia, United States

Location

Veterans Affairs, Danville

Danville, Illinois, United States

Location

VA Medical Center, Durham

Durham, North Carolina, United States

Location

Veterans Affairs, San Antonio

San Antonio, Texas, United States

Location

Related Publications (3)

• Bouquot 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 BACKGROUND

• Brachman 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 BACKGROUND

• Brennan 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 BACKGROUND

MeSH Terms

Conditions

Lichen Planus; Leukoplakia, Oral; Mouth Neoplasms; Leukoplakia

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Szabo, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: August 28, 1996
• Primary Completion: October 4, 2006
• Study Completion: July 29, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (6)