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

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.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Oral Cavity; Leukoplakia Oral
• Intervention / Treatment: Procedure: contralateral healthy tissue biopsy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital La Pitié Salpêtrière - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: contralateral healthy tissue biopsy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clonality of viral agent	RMA and HTS	30 months

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Chloé Bertolus, MD, APHP; Study Chair: Antoine Gessain, PhD, Institut Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2012
• Primary Completion (Actual): December 10, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Precancerous Conditions; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Leukoplakia
• Other Study ID Numbers: 2011-45