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

Not Applicable

• Conditions: Oropharyngeal Cancer

• 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

Study Timeline

• Study Start: 2018-01-17
• Status Verified: 2018-07
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France