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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01361100 |
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Date of registration:
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08/03/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
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Scientific title:
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Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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485 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01361100 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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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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Sophie DUSSART, MD |
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Address:
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Telephone:
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+33 478 78 27 52 |
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Email:
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sophie.dussart@lyon.unicancer.fr |
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Affiliation:
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Name:
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Philippe ZROUNBA, 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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Centre Leon Berard |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
First step:
- Man or woman aged more than 40 years
- With frequent alcohol intoxication and/or smoking
- With histologically confirmed epidermoid carcinoma of the upper aerodigestive tract
- No treatment delivered for this disease
- Signed, written informed consent
- Mandatory affiliation with a health insurance system
Second step:
- Man or woman aged more than 40 years
- With frequent alcohol intoxication and/or smoking
- With no sign of an epidermoid carcinoma of the upper aerodigestive tract
- Signed, written informed consent
- Mandatory affiliation with a health insurance system
Exclusion Criteria:
First step:
- Previous history of cancer except carcinoma in situ of the uterine cervix or skin
basal cell carcinoma treated with curative intent
- Gingivorrhagia when the test is realised
- Hypersensitivity to aspirin or to benzoate
- Asthmatic, diabetic patients or patents with chronic bronchitis requiring oxygen
therapy
- Patients taking antibiotics at enrolment or during the previous week
Second step:
- Previous history of cancer except carcinoma in situ of the uterine cervix or skin
basal cell carcinoma treated with curative intent
- Patient already treated for a cancer
- Gingivorrhagia when the test is realised
- Hypersensitivity to aspirin or to benzoate
- Asthmatic, diabetic patients or patients with chronic bronchitis requiring oxygen
therapy
- Patients on antibiotics at enrolment or during the previous week
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma
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Intervention(s)
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Device: Oncoral® test
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Primary Outcome(s)
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First step: Confirm that the parameters used for the development of the test to qualify it as positive or negative lead to the same level of sensitivity (98%)
[Time Frame: 1 year after the beginning of enrollment]
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Second step: Determine the characteristics of the Oncoral® test
[Time Frame: 2 years after the beginning of the second step enrolment]
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Secondary Outcome(s)
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First step: Estimation of test sensitivity
[Time Frame: 1 year after the beginning of enrolment]
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Second step : Estimation of test feasibility
[Time Frame: 2 years after the beginning of the second step enrolment]
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Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population
[Time Frame: 3 years after the beginning of the second step enrolment]
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Secondary ID(s)
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ET 2010-015
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ONCORAL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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