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Completed

NCT Number: NCT01636544

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.

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Key information

Conditions

Squamous Cell Carcinoma of the Oral Cavity Carcinoma Carcinoma, Squamous Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Head and Neck Neoplasms Leukokeratosis, Hereditary Mucosal Leukoplakia Oral Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hôpital la Pitié Salpêtrière - APHP

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

contralateral healthy tissue biopsy

Procedure

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.

Primary outcomes

  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 outcomes

  1. Clonality of viral agent

    Time frame: 30 months

    RMA and HTS

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Acronym: INECOC

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2012
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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