NCT01361100

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 485 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma

Interventions

Type	Name	Description
DEVICE	Oncoral® test	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2011-05-26
• Last updated: 2012-10-02

Locations

8 sites across 1 country: France