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Biomarkers for Oral Cancer
NCT00341497 · View on ClinicalTrials.gov ↗
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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00341497 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, District of Columbia, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00341497?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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