Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
NCT ID: NCT01361100
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
485 participants
INTERVENTIONAL
2010-12-31
2015-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Oncoral test
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Clinident Institute
UNKNOWN
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Philippe ZROUNBA, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU Caen Cote de Nacre
Caen, , France
Centre François Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Groupement Hospitalier Pitié Salpêtrière
Paris, , France
Institut Curie
Paris, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ET 2010-015
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONCORAL
Identifier Type: -
Identifier Source: org_study_id