Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Study Overview
Brief Summary
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Non-oropharyngeal epidermoid carcinoma
- •Oropharyngeal epidermoid carcinoma previously treated
Arms & Interventions
Patients with oropharyngeal cancer
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.
Intervention: HPV OncoTect™ (Diagnostic Test)
Outcomes
Primary Outcomes
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Time Frame: up to 12 months
Secondary Outcomes
No secondary outcomes reported