Informations générales (source: ClinicalTrials.gov)
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
Interventional
N/A
Centre Leon Berard (Voir sur ClinicalTrials)
décembre 2010
juin 2015
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Alexis Vautrin - 54511 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Groupe Hospitalier Pellegrin - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU Caen Cote de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Groupement Hospitalier Pitié Salpêtrière - 75005 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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