Clinical trial NCT01361100: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma
Keywords: Otolaryngology
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Clinident Institute
First posted: 2011-05-26
Enrollment: 485
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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%)
timeFrame: 1 year after the beginning of enrollment
measure: Second step: Determine the characteristics of the Oncoral® test
timeFrame: 2 years after the beginning of the second step enrolment
Secondary outcomes:
measure: First step: Estimation of test sensitivity
timeFrame: 1 year after the beginning of enrolment
measure: Second step : Estimation of test feasibility
timeFrame: 2 years after the beginning of the second step enrolment
measure: Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population
timeFrame: 3 years after the beginning of the second step enrolment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Groupe Hospitalier Pellegrin
city: Caen
country: France
facility: CHU Caen Cote de Nacre
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Groupement Hospitalier Pitié Salpêtrière
city: Paris
country: France
facility: Institut Curie
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Leon Berard
name: Philippe ZROUNBA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castellsague X, Quintana MJ, Martinez MC, Nieto A, Sanchez MJ, Juan A, Monner A, Carrera M, Agudo A, Quer M, Munoz N, Herrero R, Franceschi S, Bosch FX. The role of type of tobacco and type of alcoholic beverage in oral carcinogenesis. Int J Cancer. 2004 Feb 20;108(5):741-9. doi: 10.1002/ijc.11627.
citation: Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6.
citation: Nagler R, Bahar G, Shpitzer T, Feinmesser R. Concomitant analysis of salivary tumor markers--a new diagnostic tool for oral cancer. Clin Cancer Res. 2006 Jul 1;12(13):3979-84. doi: 10.1158/1078-0432.CCR-05-2412.
citation: Tavassoli M, Brunel N, Maher R, Johnson NW, Soussi T. p53 antibodies in the saliva of patients with squamous cell carcinoma of the oral cavity. Int J Cancer. 1998 Oct 29;78(3):390-1. doi: 10.1002/(SICI)1097-0215(19981029)78:33.0.CO;2-9. No abstract available.
citation: Peng G, Hakim M, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Tisch U, Haick H. Detection of lung, breast, colorectal, and prostate cancers from exhaled breath using a single array of nanosensors. Br J Cancer. 2010 Aug 10;103(4):542-51. doi: 10.1038/sj.bjc.6605810. Epub 2010 Jul 20.
citation: 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.
citation: Li Y, St John MA, Zhou X, Kim Y, Sinha U, Jordan RC, Eisele D, Abemayor E, Elashoff D, Park NH, Wong DT. Salivary transcriptome diagnostics for oral cancer detection. Clin Cancer Res. 2004 Dec 15;10(24):8442-50. doi: 10.1158/1078-0432.CCR-04-1167.
citation: El-Naggar AK, Mao L, Staerkel G, Coombes MM, Tucker SL, Luna MA, Clayman GL, Lippman S, Goepfert H. Genetic heterogeneity in saliva from patients with oral squamous carcinomas: implications in molecular diagnosis and screening. J Mol Diagn. 2001 Nov;3(4):164-70. doi: 10.1016/S1525-1578(10)60668-X.
citation: 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.
citation: Anker P, Lyautey J, Lederrey C, Stroun M. Circulating nucleic acids in plasma or serum. Clin Chim Acta. 2001 Nov;313(1-2):143-6. doi: 10.1016/s0009-8981(01)00666-0.
citation: Li Y, Zhou X, St John MA, Wong DT. RNA profiling of cell-free saliva using microarray technology. J Dent Res. 2004 Mar;83(3):199-203. doi: 10.1177/154405910408300303.
citation: Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. doi: 10.1002/cncr.11536.
citation: Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3. doi: 10.1016/S0140-6736(98)07552-7.
citation: Miekisch W, Schubert JK, Noeldge-Schomburg GF. Diagnostic potential of breath analysis--focus on volatile organic compounds. Clin Chim Acta. 2004 Sep;347(1-2):25-39. doi: 10.1016/j.cccn.2004.04.023.