Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

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.

Oncoral® test

Sophie DUSSART, MD

Justine SEMAL

Erwan DE MONES DEL PUJOL, MD

Alban PASQUIES, MD

Emmanuel BABIN, MD Ph.D

Hervé BENATEAU, MD Ph.D

Vincent PATRON, MD

Martin HITIER, MD

David BLANCHARD, MD

Abdellali ZAKHAR, MD

Marie-Yolande LOUIS, MD

Yann MALLET, MD

Jean-Louis LEFEBVRE, MD Ph.D

Marian DEGARDIN, MD

Sophie EL BEDOUI, MD

Eric LARTIGAU, MD Ph.D

Bernard COCHE-DEQUEANT, MD

Jean TON VAN, MD

Luis SCHIAPPACASSE, MD

Gauthier LEFEBVRE, MD

Louis GRAS, MD

Philippe ZROUNBA, MD

Didier GIRODET, MD

Lofti BEN SLAMA, MD

Angélique GIROD, MD

Gilles DOLIVET, MD

Sophie CORTESE, MD

Ramina MASTRONICOLA, MD

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.

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

The algorithm was first defined when the test was developed in patients on different tumour stages .

Sensitivity, specificity, positive predictive value, negative predictive value.

Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)

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...)

Clinident Institute

Centre Leon Berard

Spots Global Cancer Trial Database for oncoral® test