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

NCT ID: NCT01636544

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-15
• Study Completion Date: 2016-01-31

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.

Conditions

Squamous Cell Carcinoma of the Oral Cavity; Leukoplakia Oral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

contralateral healthy tissue biopsy

Group Type: EXPERIMENTAL

contralateral healthy tissue biopsy

Intervention Type: PROCEDURE

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.

Interventions

contralateral 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.

Intervention Type: PROCEDURE

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chloé Bertolus, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Antoine Gessain, PhD

Role: STUDY_CHAIR

Institut Pasteur

Locations

hôpital la Pitié Salpêtrière - APHP

Paris, , France

Countries

France

Other Identifiers

2011-45

Identifier Type: -

Identifier Source: org_study_id