Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity (INECOC)
This study is currently recruiting participants.
Verified April 2013 by Institut Pasteur
Sponsor:
Institut Pasteur
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
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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
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: L’Agence nationale de sécurité du médicament et des produits de santé |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Communicable Diseases Infection 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 |
ClinicalTrials.gov processed this record on May 21, 2013