Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers (HPV OncoTect™)
Primary Purpose
Oropharyngeal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HPV OncoTect™
Sponsored by
About this trial
This is an interventional diagnostic trial for Oropharyngeal Cancer
Eligibility Criteria
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
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with oropharyngeal cancer
Arm Description
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.
Outcomes
Primary Outcome Measures
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Secondary Outcome Measures
Full Information
NCT ID
NCT03604588
First Posted
July 20, 2018
Last Updated
July 20, 2018
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT03604588
Brief Title
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Acronym
HPV OncoTect™
Official Title
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with oropharyngeal cancer
Arm Type
Other
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
HPV OncoTect™
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haitham MIRGHANI, MD
Phone
0142114211
Ext
+33
Email
haitham.mirghani@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatiham MIRGHANI, MD
Phone
0142114211
Ext
+33
Email
haitham.mirghani@gustaveroussy.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
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