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Trial Title:
New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
NCT ID:
NCT06097936
Condition:
PREDICTIVE BIOMARKERS
Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC
HPV 16 Positive Oropharyngeal Tumors (OPC)
Conditions: Official terms:
Oropharyngeal Neoplasms
Conditions: Keywords:
HPV 16
oropharyngeal tumors (OPC)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HPV-ASSOCIATED OROPHARYNGEAL CANCER
Description:
The study involves the coexistence of a retrospective part, in which a group of patients
with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are
available, designed in order to evaluate the expression of HPV16-specific E5 transcript
as well as that of pEGFR and HLA, and a multicenter prospective part, involving the
enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the
outpatient clinics of the relevant LILT provincial committees, to better elucidate the
role of HPV16-E5 in identifying potentially transforming infections due to the presence
of HPV.
Arm group label:
HPV Patients
Summary:
The study involves the coexistence of a retrospective part, in which a group of patients
with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are
available, designed in order to evaluate the expression of HPV16-specific E5 transcript
as well as that of pEGFR and HLA, and a multicenter prospective part, involving the
enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the
outpatient clinics of the relevant LILT provincial committees, to better elucidate the
role of HPV16-E5 in identifying potentially transforming infections due to the presence
of HPV.
Criteria for eligibility:
Study pop:
The control group will be enlisted from among the subjects referred to the IRE outpatient
clinic and/or the outpatient clinics of the LILT Provincial Committees collaborating with
the Project to undergo a screening/checkup visit.
Samples will be collected in a mouthwash (i.e., Listerine) and stored in suitable
solution to preserve nucleic acids (i.e., PreservCyt Transport Medium) and sent by
courier from the peripheral centers to the IFOs where they will be appropriately
analyzed.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Male subjects
- age > 18 years
- current and/or former smokers
- reporting at least 5 (Souza 2017) lifetime oral sex partners
- Written informed consent
Exclusion Criteria:
- Oral pathology
- inability to understand and sign an informed consent form
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Aldo Venuti, MD
Phone:
ND
Email:
aldo.venuti@ifo.it
Start date:
March 15, 2021
Completion date:
April 1, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of California, San Diego
Agency class:
Other
Collaborator:
Agency:
Lega Italiana per la Lotta contro i Tumori
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06097936
