Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

Study Overview
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Brief Summary
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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.

Official Title
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Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

Conditions
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Squamous Cell Carcinoma of the Oral Cavity, Leukoplakia Oral

Intervention / Treatment
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* Procedure: contralateral healthy tissue biopsy


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: contralateral healthy tissue biopsy<br> | Procedure: contralateral healthy tissue biopsy<br>* At the time of surgery, a part of the specimen, plus a biopsy of the healthy (control) contralateral mucosa (i.e. right border of the tongue for a SCC of the left border, left cheek for a dysplasia of the right cheek and so on) will be harvested for research and immediately frozen at -80°C first in dry ice, then in a -80°C freezer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. | qPCR method | 30 months | 
| Detection of others infectious agents | (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS) | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clonality of viral agent | RMA and HTS | 30 months |