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

NCT01636544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-26

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Chloé Bertolus, MD · APHP

  • Antoine Gessain, PhD · Institut Pasteur

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-15
Primary Completion
2015-12-10
Completion
2016-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636544 on ClinicalTrials.gov