Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
N/A
40 Years
N/A
40 Years
N/A
Open (Enrolling)
Both
Carcinoma
Both
Carcinoma
Trial Information
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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%)
Outcome Description:
The algorithm was first defined when the test was developed in patients on different tumour stages .
Outcome Time Frame:
1 year after the beginning of enrollment
Safety Issue:
No
Principal Investigator
Philippe ZROUNBA, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Leon Berard
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ONCORAL
NCT ID:
NCT01361100
Start Date:
December 2010
Completion Date:
June 2015
Related Keywords:
- Carcinoma
- Otolaryngology
- Carcinoma
- Carcinoma, Squamous Cell
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