Spots Global Cancer Trial Database for Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

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Trial Identification

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

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

Study ID: NCT01361100

Conditions

Carcinoma

Interventions

Oncoral® test

Study Description

Brief Summary: 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.

Detailed Description: