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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Centre Leon Berard
Sponsor:
Collaborator:
Clinident Institute
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01361100
First received: March 8, 2011
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Carcinoma
Device: Oncoral® test

Study Type: Interventional
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

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 485
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361100

Contacts
Contact: Sophie DUSSART, MD +33 478 78 27 52 sophie.dussart@lyon.unicancer.fr
Contact: Justine SEMAL +33 478 78 29 22 justine.semal@lyon.unicancer.fr

Locations
France
CHU Bordeaux - Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33076
Principal Investigator: Erwan DE MONES DEL PUJOL, MD         
Sub-Investigator: Alban PASQUIES, MD         
Centre François Baclesse Not yet recruiting
Caen, France, 14076
Principal Investigator: Marie-Yolande LOUIS, MD         
CHU Caen Cote de Nacre Recruiting
Caen, France, 14033
Principal Investigator: Emmanuel BABIN, MD Ph.D         
Sub-Investigator: Hervé BENATEAU, MD Ph.D         
Sub-Investigator: Vincent PATRON, MD         
Sub-Investigator: Martin HITIER, MD         
Sub-Investigator: David BLANCHARD, MD         
Sub-Investigator: Abdellali ZAKHAR, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Principal Investigator: Yann MALLET, MD         
Sub-Investigator: Jean-Louis LEFEBVRE, MD Ph.D         
Sub-Investigator: Marian DEGARDIN, MD         
Sub-Investigator: Sophie EL BEDOUI, MD         
Sub-Investigator: Eric LARTIGAU, MD Ph.D         
Sub-Investigator: Bernard COCHE-DEQUEANT, MD         
Sub-Investigator: Jean TON VAN, MD         
Sub-Investigator: Luis SCHIAPPACASSE, MD         
Sub-Investigator: Gauthier LEFEBVRE, MD         
Sub-Investigator: Louis GRAS, MD         
Centre Leon Berard Recruiting
Lyon, France, 69008
Principal Investigator: Philippe ZROUNBA, MD         
Sub-Investigator: Didier GIRODET, MD         
Groupement Hospitalier Pitié Salpêtrière Not yet recruiting
Paris, France, 75005
Principal Investigator: Lofti BEN SLAMA, MD         
Institut Curie Recruiting
Paris, France, 75005
Principal Investigator: Angélique GIROD, MD         
Centre Alexis Vautrin Recruiting
Vandoeuvre Les Nancy, France, 54511
Principal Investigator: Gilles DOLIVET, MD         
Sub-Investigator: Sophie CORTESE, MD         
Sub-Investigator: Ramina MASTRONICOLA, MD         
Sponsors and Collaborators
Centre Leon Berard
Clinident Institute
Investigators
Principal Investigator: Philippe ZROUNBA, MD Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01361100     History of Changes
Other Study ID Numbers: ONCORAL, ET 2010-015
Study First Received: March 8, 2011
Last Updated: October 1, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Otolaryngology

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 27, 2014