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

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma of the Oral Cavity; Leukoplakia Oral
• Interventions: Procedure: contralateral healthy tissue biopsy

• Registration Number: NCT01636544
• Lead Sponsor: Institut Pasteur

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 Description

Not available

Study Timeline

• Study Start: 2012-06-15
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Primary Completion: 2015-12-10
• Study Completion: 2016-01-31
• Status Verified: 2019-08
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
contralateral healthy tissue biopsy	contralateral healthy tissue biopsy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clonality of viral agent	30 months	RMA and HTS

Trial Locations

Locations (1)

hôpital la Pitié Salpêtrière - APHP; 🇫🇷 Paris, France