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

Primary Purpose

Squamous Cell Carcinoma of the Oral Cavity, Leukoplakia Oral

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

contralateral healthy tissue biopsy

About this trial

This is an interventional basic science trial for Squamous Cell Carcinoma of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

hôpital la Pitié Salpêtrière - APHP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

contralateral healthy tissue biopsy

Arm Description

Outcomes

Primary Outcome Measures

Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.

qPCR method

Detection of others infectious agents

(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)

Secondary Outcome Measures

Clonality of viral agent

RMA and HTS

Full Information

NCT ID

NCT01636544

First Posted

July 6, 2012

Last Updated

April 19, 2022

Sponsor

Institut Pasteur

1. Study Identification

Unique Protocol Identification Number

NCT01636544

Brief Title

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

Acronym

INECOC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

June 15, 2012 (Actual)

Primary Completion Date

December 10, 2015 (Actual)

Study Completion Date

January 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Pasteur

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Oral Cavity, Leukoplakia Oral

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

contralateral healthy tissue biopsy

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

contralateral healthy tissue biopsy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.

Description

qPCR method

Time Frame

30 months

Title

Detection of others infectious agents

Description

(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)

Time Frame

30 months

Secondary Outcome Measure Information:

Title

Clonality of viral agent

Description

RMA and HTS

Time Frame

30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chloé Bertolus, MD

Organizational Affiliation

APHP

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Antoine Gessain, PhD

Organizational Affiliation

Institut Pasteur

Official's Role

Study Chair

Facility Information:

Facility Name

hôpital la Pitié Salpêtrière - APHP

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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