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

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

— INECOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636544
• Other study ID #: 2011-45
• Status: Completed
• Phase: N/A
• Start date: June 15, 2012
• Est. completion date: January 31, 2016

Study information

• Verified date: August 2019
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2016
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Leukoplakia
• Leukoplakia Oral
• Squamous Cell Carcinoma of the Oral Cavity

Intervention

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.

Locations

Country	Name	City	State
France	hôpital la Pitié Salpêtrière - APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.	qPCR method	30 months
Primary	Detection of others infectious agents	(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)	30 months
Secondary	Clonality of viral agent	RMA and HTS	30 months