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

NCT01636544 | Completed

• 1 other identifier: 2011-45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clonality of viral agent

  30 months

Study Arms (1)

contralateral healthy tissue biopsy

EXPERIMENTAL

Procedure: contralateral healthy tissue biopsy

Interventions

contralateral healthy tissue biopsy 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.

contralateral healthy tissue biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous treatment of oral cancer,

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

hôpital la Pitié Salpêtrière - APHP

Paris, 75013, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Leukokeratosis, Hereditary Mucosal

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chloé Bertolus, MD

  APHP

  PRINCIPAL INVESTIGATOR

• Antoine Gessain, PhD

  Institut Pasteur

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: June 15, 2012
• Primary Completion: December 10, 2015
• Study Completion: January 31, 2016
• Last Updated: April 26, 2022

Record last verified: 2019-08

Locations

FR (1)