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

NCT01361100 | Unknown

• 2 other identifiers: ONCORALET 2010-015
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 8

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.

Conditions

Carcinoma

Keywords

Otolaryngology

Outcome Measures

Primary Outcomes (2)

• 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 .

  1 year after the beginning of enrollment

• Second step: Determine the characteristics of the Oncoral® test

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

  2 years after the beginning of the second step enrolment

Secondary Outcomes (3)

• First step: Estimation of test sensitivity

  1 year after the beginning of enrolment

• Second step : Estimation of test feasibility

  2 years after the beginning of the second step enrolment

• 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

Study Arms (1)

Oncoral test

EXPERIMENTAL

Device: Oncoral® test

Interventions

Oncoral® test DEVICE

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.

Oncoral test

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• Clinident Institute: collaborator

Study Sites (8)

CHU Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

RECRUITING

CHU Caen Cote de Nacre

Caen, 14033, France

RECRUITING

Centre François Baclesse

Caen, 14076, France

NOT YET RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Groupement Hospitalier Pitié Salpêtrière

Paris, 75005, France

NOT YET RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (14)

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  PMID: 9766578 BACKGROUND

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  PMID: 20648015 BACKGROUND

• Mager DL, Haffajee AD, Devlin PM, Norris CM, Posner MR, Goodson JM. The salivary microbiota as a diagnostic indicator of oral cancer: a descriptive, non-randomized study of cancer-free and oral squamous cell carcinoma subjects. J Transl Med. 2005 Jul 7;3:27. doi: 10.1186/1479-5876-3-27.

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• Liao PH, Chang YC, Huang MF, Tai KW, Chou MY. Mutation of p53 gene codon 63 in saliva as a molecular marker for oral squamous cell carcinomas. Oral Oncol. 2000 May;36(3):272-6. doi: 10.1016/s1368-8375(00)00005-1.

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  PMID: 15313139 BACKGROUND

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Philippe ZROUNBA, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie DUSSART, MD

CONTACT

+33 478 78 27 52; sophie.dussart@lyon.unicancer.fr

Justine SEMAL

CONTACT

+33 478 78 29 22; justine.semal@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: May 26, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 2, 2012

Record last verified: 2012-10

Locations

FR (8)