Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity (INECOC)
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About
Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.
Enrollment
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Inclusion criteria
- Patient over 18 years,
- For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
- For subgroup "OSCC" : histological diagnosis of OSCC,
- Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
- Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
- Informed consent signed.
Exclusion criteria
• Previous treatment of oral cancer,
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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