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

Not Applicable

• Conditions: Carcinoma
• Interventions: Device: Oncoral® test

• Registration Number: NCT01361100
• Lead Sponsor: Centre Leon Berard

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

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

First step:

• Man or woman aged more than 40 years
• With frequent alcohol intoxication and/or smoking
• With histologically confirmed epidermoid carcinoma of the upper aerodigestive tract
• No treatment delivered for this disease
• Signed, written informed consent
• Mandatory affiliation with a health insurance system

Second step:

• Man or woman aged more than 40 years
• With frequent alcohol intoxication and/or smoking
• With no sign of an epidermoid carcinoma of the upper aerodigestive tract
• Signed, written informed consent
• Mandatory affiliation with a health insurance system

Exclusion Criteria

First step:

• Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
• Gingivorrhagia when the test is realised
• Hypersensitivity to aspirin or to benzoate
• Asthmatic, diabetic patients or patents with chronic bronchitis requiring oxygen therapy
• Patients taking antibiotics at enrolment or during the previous week

Second step:

• Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
• Patient already treated for a cancer
• Gingivorrhagia when the test is realised
• Hypersensitivity to aspirin or to benzoate
• Asthmatic, diabetic patients or patients with chronic bronchitis requiring oxygen therapy
• Patients on antibiotics at enrolment or during the previous week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncoral test	Oncoral® test	-

Primary Outcome Measures

Name	Time	Method
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%)	1 year after the beginning of enrollment	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	2 years after the beginning of the second step enrolment	Sensitivity, specificity, positive predictive value, negative predictive value.

Secondary Outcome Measures

Name	Time	Method
First step: Estimation of test sensitivity	1 year after the beginning of enrolment	Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)
Second step : Estimation of test feasibility	2 years after the beginning of the second step enrolment	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	3 years after the beginning of the second step enrolment

Trial Locations

Locations (8)

CHU Caen Cote de Nacre; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre Les Nancy, France

Groupement Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France

CHU Bordeaux - Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Curie; 🇫🇷 Paris, France