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

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ClinicalTrials.gov Identifier: NCT01636544
Recruitment Status : Unknown
Verified April 2013 by Institut Pasteur.
Recruitment status was:  Recruiting
First Posted : July 10, 2012
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Oral Cavity Leukoplakia Oral Procedure: contralateral healthy tissue biopsy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
Study Start Date : June 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: contralateral healthy tissue biopsy 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.


Outcome Measures

Primary Outcome Measures :
  1. Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. [ Time Frame: 30 months ]
    qPCR method

  2. Detection of others infectious agents [ Time Frame: 30 months ]
    (i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)


Secondary Outcome Measures :
  1. Clonality of viral agent [ Time Frame: 30 months ]
    RMA and HTS


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636544


Contacts
Contact: Nicolas Berthet nicolas.berthet@pasteur.fr

Locations
France
hôpital la Pitié Salpêtrière - APHP Recruiting
Paris, France, 75013
Contact: Chloé Bertolus, MD       chloe.bertolus@psl.aphp.fr   
Sponsors and Collaborators
Institut Pasteur
Investigators
Principal Investigator: Chloé Bertolus, MD APHP
Study Chair: Antoine Gessain, PhD Institut Pasteur
More Information

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT01636544     History of Changes
Other Study ID Numbers: 2011-45
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Leukoplakia
Leukoplakia, Oral
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Precancerous Conditions
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases