NCT01636544|Completed
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
INECOC
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INECOC
Sponsor study identifier
interventional
100
1 country
1
Study Start
June 15, 2012
Actual (reported)Primary Completion
December 10, 2015
Actual (reported)Study Completion
January 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2012
Actual (reported)July 6, 2012
Actual (reported)July 10, 2012
Actual (reported)December 10, 2015
Actual (reported)January 31, 2016
Actual (reported)Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
qPCR method
30 months
Detection of others infectious agents
(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
30 months
Clonality of viral agent
30 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
hôpital la Pitié Salpêtrière - APHP
Paris, 75013, France
Chloé Bertolus, MD
APHP
Antoine Gessain, PhD
Institut Pasteur
100 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2012
First Posted
July 10, 2012
Study Start
June 15, 2012
Actual (reported)A Randomized Study of Sulindac in Oral Premalignant Lesions
Contact the study team to confirm eligibility.
Primary Completion
December 10, 2015
Actual (reported)Study Completion
January 31, 2016
Actual (reported)Last Updated
April 26, 2022
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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