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NCT00341497 · ClinicalTrials.gov registry record
Biomarkers for Oral Cancer
A clinical trial of Oral Leukoplakia and Lichen Planus, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 80
- Enrollment target
- 6
- Study locations
NCT00341497 is a study of Oral Leukoplakia and Lichen Planus that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, above the 30-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (167% higher). The trial reports 6 study locations across 6 states.
The verdict
NCT00341497, a study of Oral Leukoplakia and Lichen Planus, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
- 6
- Study locations
Study 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
Conditions Studied
Study Locations (6)
California
- U.C.S.F./ Vterans Affairs Medical Center - San Francisco
District of Columbia
- VA Medical Center, Washington D.C. - Washington D.C.
Georgia
- VA Medical Ctr, Atlanta - Atlanta
Illinois
- Veterans Affairs, Danville - Danville
North Carolina
- VA Medical Center, Durham - Durham
Texas
- Veterans Affairs, San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 1996-08-28 |
| Est. Completion | 2025-07-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00341497
The ClinicalTrials.gov registry entry for NCT00341497 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 30-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (167% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 0 interventions.
NCT00341497 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, District of Columbia, Georgia.
Frequently Asked Questions
What is clinical trial NCT00341497 about?
NCT00341497 is a clinical study titled "Biomarkers for Oral Cancer". 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) contr...
What is the current status of trial NCT00341497?
This trial is currently completed. The enrollment target is 80 participants. The study started on 1996-08-28. Estimated completion is 2025-07-29.
What conditions does trial NCT00341497 study?
This clinical trial studies the following conditions: Oral Leukoplakia, Lichen Planus, Mouth Neoplasms.
Who is sponsoring clinical trial NCT00341497?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00341497 being conducted?
This trial has 6 study locations across California, District of Columbia, Georgia, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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