Clinical trial · Interventional
Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
NCT01361100CI-TRIAL-00008185unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncoral® test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oncoral test
- interventionNames
- Device: Oncoral® test
Primary outcomes (2)
- 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
- description
- The algorithm was first defined when the test was developed in patients on different tumour stages .
- measure
- Second step: Determine the characteristics of the Oncoral® test
- timeFrame
- 2 years after the beginning of the second step enrolment
- description
- Sensitivity, specificity, positive predictive value, negative predictive value.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (14)
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- BACKGROUNDTavassoli 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. PMID 9766578
- BACKGROUNDPeng 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. PMID 20648015
- BACKGROUNDMager 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. PMID 15987522
- BACKGROUNDLi 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.