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

N/AUnknownNCT03604588

Gustave Roussy, Cancer Campus, Grand Paris40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Oropharyngeal Cancer

Interventions

HPV OncoTect™DIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gustave Roussy

Villejuif, Val De Marne, France

RECRUITING

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

Central Contacts

Haitham MIRGHANI, MD

CONTACT

0142114211 haitham.mirghani@gustaveroussy.fr

Data from ClinicalTrials.gov

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