Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers (HPV OncoTect™)

Gustave Roussy

Status: Unknown

Conditions: Oropharyngeal Cancer

Treatments: Diagnostic Test: HPV OncoTect™

Study type: Interventional

Funder types: Other

Identifiers

NCT03604588

2016/2474 (Other Identifier)

2016-A01655-46

Details and patient eligibility

About

To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Untreated oropharynx epidermoid carcinoma
2. Patient ≥ 18 years old
3. Patient affiliated to a social security scheme or beneficiary of such a scheme
4. Information to the patient or his legal representative and signature of informed consent

Exclusion criteria

1. Non-oropharyngeal epidermoid carcinoma
2. Oropharyngeal epidermoid carcinoma previously treated

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Patients with oropharyngeal cancer

Other group

Description:

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.

Treatment:

Diagnostic Test: HPV OncoTect™