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

Primary Purpose

Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oncoral® test
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma focused on measuring Otolaryngology

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Bordeaux - Groupe Hospitalier PellegrinRecruiting
  • CHU Caen Cote de NacreRecruiting
  • Centre François Baclesse
  • Centre Oscar LambretRecruiting
  • Centre Leon BerardRecruiting
  • Groupement Hospitalier Pitié Salpêtrière
  • Institut CurieRecruiting
  • Centre Alexis VautrinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oncoral test

Arm Description

Outcomes

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%)
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
Sensitivity, specificity, positive predictive value, negative predictive value.

Secondary Outcome Measures

First step: Estimation of test sensitivity
Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)
Second step : Estimation of test feasibility
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

Full Information

First Posted
March 8, 2011
Last Updated
October 1, 2012
Sponsor
Centre Leon Berard
Collaborators
Clinident Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01361100
Brief Title
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
Official Title
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Clinident Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma
Keywords
Otolaryngology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
485 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncoral test
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Oncoral® test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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%)
Description
The algorithm was first defined when the test was developed in patients on different tumour stages .
Time Frame
1 year after the beginning of enrollment
Title
Second step: Determine the characteristics of the Oncoral® test
Description
Sensitivity, specificity, positive predictive value, negative predictive value.
Time Frame
2 years after the beginning of the second step enrolment
Secondary Outcome Measure Information:
Title
First step: Estimation of test sensitivity
Description
Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)
Time Frame
1 year after the beginning of enrolment
Title
Second step : Estimation of test feasibility
Description
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...)
Time Frame
2 years after the beginning of the second step enrolment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie DUSSART, MD
Phone
+33 478 78 27 52
Email
sophie.dussart@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Justine SEMAL
Phone
+33 478 78 29 22
Email
justine.semal@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ZROUNBA, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux - Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwan DE MONES DEL PUJOL, MD
First Name & Middle Initial & Last Name & Degree
Alban PASQUIES, MD
Facility Name
CHU Caen Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel BABIN, MD Ph.D
First Name & Middle Initial & Last Name & Degree
Hervé BENATEAU, MD Ph.D
First Name & Middle Initial & Last Name & Degree
Vincent PATRON, MD
First Name & Middle Initial & Last Name & Degree
Martin HITIER, MD
First Name & Middle Initial & Last Name & Degree
David BLANCHARD, MD
First Name & Middle Initial & Last Name & Degree
Abdellali ZAKHAR, MD
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Yolande LOUIS, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann MALLET, MD
First Name & Middle Initial & Last Name & Degree
Jean-Louis LEFEBVRE, MD Ph.D
First Name & Middle Initial & Last Name & Degree
Marian DEGARDIN, MD
First Name & Middle Initial & Last Name & Degree
Sophie EL BEDOUI, MD
First Name & Middle Initial & Last Name & Degree
Eric LARTIGAU, MD Ph.D
First Name & Middle Initial & Last Name & Degree
Bernard COCHE-DEQUEANT, MD
First Name & Middle Initial & Last Name & Degree
Jean TON VAN, MD
First Name & Middle Initial & Last Name & Degree
Luis SCHIAPPACASSE, MD
First Name & Middle Initial & Last Name & Degree
Gauthier LEFEBVRE, MD
First Name & Middle Initial & Last Name & Degree
Louis GRAS, MD
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ZROUNBA, MD
First Name & Middle Initial & Last Name & Degree
Didier GIRODET, MD
Facility Name
Groupement Hospitalier Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lofti BEN SLAMA, MD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélique GIROD, MD
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles DOLIVET, MD
First Name & Middle Initial & Last Name & Degree
Sophie CORTESE, MD
First Name & Middle Initial & Last Name & Degree
Ramina MASTRONICOLA, MD

12. IPD Sharing Statement

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

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