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
  Purpose

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 Intervention
Squamous Cell Carcinoma of the Oral Cavity
Leukoplakia Oral
Procedure: contralateral healthy tissue biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

Resource links provided by NLM:


Further study details as provided by Institut Pasteur:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Clonality of viral agent [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    RMA and HTS


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT01636544     History of Changes
Other Study ID Numbers: 2011-45
Study First Received: July 6, 2012
Last Updated: April 4, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on October 29, 2014