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

Oropharyngeal Cancer Clinical Trial

— HPV OncoTect™  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03604588
• Other study ID #: 2016-A01655-46
• Secondary ID: 2016/2474
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: January 2019

Study information

• Verified date: July 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Haitham MIRGHANI, MD
• Phone: 0142114211
• Email: haitham.mirghani[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.		up to 12 months