Leukoplakia Oral, Squamous Cell Carcinoma of the Oral Cavity
Conditions
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.
Interventions
PROCEDUREcontralateral healthy tissue biopsy
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.
Sponsors
Institut Pasteur
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. | 30 months | qPCR method |
| Detection of others infectious agents | 30 months | (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clonality of viral agent | 30 months | RMA and HTS |
Countries
France
Outcome results
None listed