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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604588
Acronym
HPV OncoTect™
Enrollment
40
Registered
2018-07-27
Start date
2018-01-17
Completion date
2019-01-31
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Cancer

Brief summary

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

Interventions

DIAGNOSTIC_TESTHPV 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.

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.up to 12 months

Countries

France

Contacts

Primary ContactHaitham MIRGHANI, MD
haitham.mirghani@gustaveroussy.fr0142114211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026