Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
HPV OncoTect™
2 other identifiers
interventional
40
1 country
1
Brief Summary
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2018
CompletedFirst Submitted
Initial submission to the registry
July 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJuly 27, 2018
July 1, 2018
12 months
July 20, 2018
July 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
up to 12 months
Study Arms (1)
Patients with oropharyngeal cancer
OTHERSalivary 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.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Non-oropharyngeal epidermoid carcinoma
- Oropharyngeal epidermoid carcinoma previously treated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gustave Roussy
Villejuif, Val De Marne, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
July 27, 2018
Study Start
January 17, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
July 27, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share