Biomarkers for Oral Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341497
First received: June 19, 2006
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition
Oral Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biomarkers for Oral Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • New or re-emergence of oral lesion [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: August 1996
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341497

Locations
United States, California
U.C.S.F./ Vterans Affairs Medical Center
San Francisco, California, United States, 94143
United States, District of Columbia
VA Medical Center, Washington D.C.
Washington, District of Columbia, United States, 20422
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322-1102
United States, Illinois
Veterans Affairs, Danville
Danville, Illinois, United States
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States
United States, Texas
Veterans Affairs, San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah M Winn, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341497     History of Changes
Other Study ID Numbers: 999998040, OH98-D-N040
Study First Received: June 19, 2006
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Leukoplakia
Oral Mucosa
Biomarkers

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases

ClinicalTrials.gov processed this record on August 19, 2014