Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Sponsor
- Institut Pasteur
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Detection of others infectious agents
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
Detection of others infectious agents
Time Frame: 30 months
(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
Time Frame: 30 months
qPCR method
Secondary Outcomes
- Clonality of viral agent(30 months)