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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Institut Pasteur
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT01636544
First received: July 6, 2012
Last updated: April 4, 2013
Last verified: April 2013

July 6, 2012
April 4, 2013
June 2012
February 2015   (final data collection date for primary outcome measure)
  • Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    qPCR method
  • Detection of others infectious agents [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
  • Detection and characterization of HPV by using qPCR method. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    qPCR method
  • Detection of others infectious agents [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
Complete list of historical versions of study NCT01636544 on ClinicalTrials.gov Archive Site
Clonality of viral agent [ Time Frame: 30 months ] [ Designated as safety issue: No ]
RMA and HTS
Same as current
Not Provided
Not Provided
 
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Squamous Cell Carcinoma of the Oral Cavity
  • Leukoplakia Oral
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.
Experimental: contralateral healthy tissue biopsy
Intervention: Procedure: contralateral healthy tissue biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
February 2015   (final data collection date for primary outcome measure)

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,

Both
18 Years and older
No
Contact: Nicolas Berthet nicolas.berthet@pasteur.fr
France
 
NCT01636544
2011-45
No
Institut Pasteur
Institut Pasteur
Not Provided
Principal Investigator: Chloé Bertolus, MD APHP
Study Chair: Antoine Gessain, PhD Institut Pasteur
Institut Pasteur
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP