Biomarkers for Oral Cancer : Biomarkers for Oral Cancer

This longitudinal research project is part of a long-term effort by the National Cancer Institute and the National Institute of Dental and Craniofacial Research to improve modalities for prevention, early detection, and treatment of oral cancers. This is a natural history study designed to identify markers or early malignant transformation that potentially could be used in predicting which oral soft tissues are most likely to lead to oral cancer.Persons with white, red, or red/white oral mucosal lesions seen at six Veterans Affairs hospitals in the United States will be selected for the study. Study subjects will undergo a biopsy of all suspect oral lesions. At this baseline examination, the patient will complete a consent form and a questionnaire which will obtain data on potential modifiers of the relationship between histopathology and molecular marker status such as sociodemographic characteristics, tobacco and alcohol use, and medical history. A clinician will describe and photograph the lesion. In addition, the mucosa will be gently scraped to obtain buccal cells. Selected data on dental and medical characteristics of study subjects will be extracted from computerized VA hospital data bases. Biopsy specimens will be analyzed using immunohistochemical and molecular biological approaches to describe their pathological status and to assess the presence of specific molecular events. The analysis of molecular markers may include tests of the presence or activity of certain molecules thought to be associated with the malignant phenotype including p53-dependent growth suppressors, pRb-dependent growth control factors, growth factor receptor-modulated pathways, carcinogen-metabolizing alleles and functioning, and viral agents. To ensure that the best possible scientific paradigm for early malignant changes is tested using this study population, decisions about which genetic and immunohistological assays to conduct on the biopsy material will be made by consensus of the principal and coinvestigators at the time that an adequate sample size is achieved. When biological assays are complete, statistical analysis will determine associations between molecular markers from the oral lesions and the lesions' histopathology and will examine how environmental, behavioral, and sociodemographic factors influence these associations.Study subjects will then be followed longitudinally over a two-year period to ascertain recurrence of lesions. These study subjects will be asked to return to the dental clinics every 4 months during the first year of the study and every 6 months during the second year. At each visit the patient will receive the same oral examination as at baseline. The patient will be classified as having normal-appearing mucosa or an oral lesion. If a lesion is present, it will be evaluated and characterized as at the baseline and then biopsied. Patients not returning on schedule will be traced, contacted and asked to return for an evaluation. Changes in histopathology and the relationship of these changes to changes in biomarker levels will be examined.Subjects will be informed that if a gene or genetic change that might be useful for patients with oral lesions is identified, they will be contacted to see whether they would like to have information on which gene types may be associated with oral cancer risk. At that time, prior to making a decision, they will be informed of the various risks and consequences of obtaining such information.After 14 years, development of new lesions will be identified through 2020 through medical and 3 dental record review and patients vital status and cause of death will be ascertained..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 19. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Leukoplakia Leukoplakia, Oral Lichen Planus Mouth Neoplasms Recruitment Status: Active, not recruiting Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: June 21, 2006, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024

Study ID:

NCT00341497 999998040 OH98-D-N040

Veröffentlichungen zur Studie:

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. 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. 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.

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PPN (Katalog-ID):	CTG000300810