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Clinical Trials/NCT03604588
NCT03604588UnknownNot Applicable

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

Gustave Roussy, Cancer Campus, Grand Paris2 sites in 1 country40 target enrollmentStarted: January 17, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
2
Primary Endpoint
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Non-oropharyngeal epidermoid carcinoma
  • Oropharyngeal epidermoid carcinoma previously treated

Arms & Interventions

Patients with oropharyngeal cancer

Other

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.

Intervention: HPV OncoTect™ (Diagnostic Test)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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