Carcinoma Clinical Trial
Official title:
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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