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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2022 |
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Main ID: |
NCT01636544 |
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Date of registration:
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06/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
INECOC |
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Scientific title:
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Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity |
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Date of first enrolment:
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June 15, 2012 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01636544 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Antoine Gessain, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Pasteur |
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Name:
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Chloé Bertolus, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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APHP |
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Key inclusion & exclusion criteria
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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,
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leukoplakia Oral
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Squamous Cell Carcinoma of the Oral Cavity
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Intervention(s)
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Procedure: contralateral healthy tissue biopsy
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Primary Outcome(s)
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Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
[Time Frame: 30 months]
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Detection of others infectious agents
[Time Frame: 30 months]
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Secondary Outcome(s)
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Clonality of viral agent
[Time Frame: 30 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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