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

Léon Bérard Center

Status

Unknown

Conditions

Carcinoma

Treatments

Device: Oncoral® test

Study type

Interventional

Funder types

Other

Identifiers

NCT01361100

ONCORAL

ET 2010-015 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

485 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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