Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Not Applicable
- Conditions
- Oropharyngeal Cancer
- Interventions
- Diagnostic Test: HPV OncoTect™
- Registration Number
- NCT03604588
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Untreated oropharynx epidermoid carcinoma
- Patient ≥ 18 years old
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- Information to the patient or his legal representative and signature of informed consent
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Exclusion Criteria
- Non-oropharyngeal epidermoid carcinoma
- Oropharyngeal epidermoid carcinoma previously treated
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with oropharyngeal cancer HPV OncoTect™ Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test. Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.
- Primary Outcome Measures
Name Time Method Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced. up to 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gustave Roussy
🇫🇷Villejuif, Val De Marne, France