Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
Recruitment status was: Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract|
- 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%) [ Time Frame: 1 year after the beginning of enrollment ] [ Designated as safety issue: No ]The algorithm was first defined when the test was developed in patients on different tumour stages .
- Second step: Determine the characteristics of the Oncoral® test [ Time Frame: 2 years after the beginning of the second step enrolment ] [ Designated as safety issue: No ]Sensitivity, specificity, positive predictive value, negative predictive value.
- First step: Estimation of test sensitivity [ Time Frame: 1 year after the beginning of enrolment ] [ Designated as safety issue: No ]Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)
- Second step : Estimation of test feasibility [ Time Frame: 2 years after the beginning of the second step enrolment ] [ Designated as safety issue: No ]
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...)
- Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population [ Time Frame: 3 years after the beginning of the second step enrolment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: Oncoral test||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361100
|CHU Bordeaux - Groupe Hospitalier Pellegrin|
|Bordeaux, France, 33076|
|CHU Caen Cote de Nacre|
|Caen, France, 14033|
|Centre François Baclesse|
|Caen, France, 14076|
|Centre Oscar Lambret|
|Lille, France, 59000|
|Centre Leon Berard|
|Lyon, France, 69008|
|Groupement Hospitalier Pitié Salpêtrière|
|Paris, France, 75005|
|Paris, France, 75005|
|Centre Alexis Vautrin|
|Vandoeuvre Les Nancy, France, 54511|
|Principal Investigator:||Philippe ZROUNBA, MD||Centre Leon Berard|