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

April 19, 2022 updated by: Institut Pasteur
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 30 months
qPCR method
30 months
Detection of others infectious agents
Time Frame: 30 months
(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
Time Frame: 30 months
RMA and HTS
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 2011-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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