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| ID | Type | Description | Link |
|---|---|---|---|
| ET 2010-015 | Registry Identifier | Sponsor's number |
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| Name | Class |
|---|---|
| Clinident Institute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoral test | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| First step: Estimation of test sensitivity | Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives) | 1 year after the beginning of enrolment |
| Second step : Estimation of test feasibility |
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Inclusion Criteria:
First step:
Second step:
Exclusion Criteria:
First step:
Second step:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Philippe ZROUNBA, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux - Groupe Hospitalier Pellegrin | Recruiting | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14696101 | Background | 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. | |
| 17825602 | Background |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
Feasibility will be assessed by :
| 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 |
| CHU Caen Cote de Nacre | Recruiting | Caen | 14033 | France |
|
| Centre François Baclesse | Not yet recruiting | Caen | 14076 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
|
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
|
| Groupement Hospitalier Pitié Salpêtrière | Not yet recruiting | Paris | 75005 | France |
|
| Institut Curie | Recruiting | Paris | 75005 | France |
|
| Centre Alexis Vautrin | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
|
| 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. |
| 16818695 | Background | 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. |
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| 15623624 | Background | 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. |
| 11687600 | Background | 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. |
| 10793330 | Background | 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. |
| 11694252 | Background | 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. |
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| 12910517 | Background | 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. |
| 10371572 | Background | 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. |
| 15313139 | Background | 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. |