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
Sponsored by
About this trial
This is an interventional basic science trial for Squamous Cell Carcinoma of the Oral Cavity
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,
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
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
No
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
No
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
We'll reach out to this number within 24 hrs