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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Institut Pasteur

Current Primary Outcome:

  • Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. [ Time Frame: 30 months ]
    qPCR method
  • Detection of others infectious agents [ Time Frame: 30 months ]
    (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)


Original Primary Outcome:

  • Detection and characterization of HPV by using qPCR method. [ Time Frame: 30 months ]
    qPCR method
  • Detection of others infectious agents [ Time Frame: 30 months ]
    (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)


Current Secondary Outcome: Clonality of viral agent [ Time Frame: 30 months ]

RMA and HTS


Original Secondary Outcome: Same as current

Information By: Institut Pasteur

Dates:
Date Received: July 6, 2012
Date Started: June 2012
Date Completion: July 2015
Last Updated: April 4, 2013
Last Verified: April 2013