Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

Study Overview
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Brief Summary
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This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months. If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.

Official Title
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Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

Conditions
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Carcinoma

Intervention / Treatment
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* Device: Oncoral® test


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncoral test<br> | Device: Oncoral® test<br>* The patient rinses his oral cavity for 2 minutes. Then he screws lid back onto a beaker. The investigator holds the beaker straight so that the end of the aspiration mouth is dipped into the liquid. Then, the investigators takes 2 tubes and pushes them one after the other down on the opening of the beaker. The tubes should fill by themselves. The tubes can't be kept more than eleven days and are send to the Clinident Institute for the analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) | The algorithm was first defined when the test was developed in patients on different tumour stages . | 1 year after the beginning of enrollment | 
| Second step: Determine the characteristics of the Oncoral® test | Sensitivity, specificity, positive predictive value, negative predictive value. | 2 years after the beginning of the second step enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First step: Estimation of test sensitivity | Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives) | 1 year after the beginning of enrolment | 
| Second step : Estimation of test feasibility | Feasibility will be assessed by : the rate of patients who were not able to realise the test (difficulty to rinse the oral cavity) the rate of tests that cannot be analysed (inadequate tests, problems of stability, difficulties with the extraction of volatile molecules, DNA or mRNA...) If the rate of unusable tests is greater than 10%, corrective actions will be necessary in order to use this test in the future. These actions will be considered according to the type of problems (adjustments of the test, transport...) | 2 years after the beginning of the second step enrolment | 
| Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population |  | 3 years after the beginning of the second step enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otolaryngology