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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01636544
Date of registration: 06/07/2012
Prospective Registration: Yes
Primary sponsor: Institut Pasteur
Public title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity INECOC
Scientific title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Date of first enrolment: June 2012
Target sample size: 100
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01636544
Study type:  Interventional
Study design:  Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Chloé Bertolus, MD
Address: 
Telephone:
Email: chloe.bertolus@psl.aphp.fr
Affiliation: 
Name:     Nicolas Berthet
Address: 
Telephone:
Email: nicolas.berthet@pasteur.fr
Affiliation: 
Name:     Chloé Bertolus, MD
Address: 
Telephone:
Email:
Affiliation:  APHP
Name:     Antoine Gessain, PhD
Address: 
Telephone:
Email:
Affiliation:  Institut Pasteur
Key inclusion & exclusion 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,



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Leukoplakia Oral
Squamous Cell Carcinoma of the Oral Cavity
Intervention(s)
Procedure: contralateral healthy tissue biopsy
Primary Outcome(s)
Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. [Time Frame: 30 months]
Detection of others infectious agents [Time Frame: 30 months]
Secondary Outcome(s)
Clonality of viral agent [Time Frame: 30 months]
Secondary ID(s)
2011-45
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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