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Trial Title:
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
NCT ID:
NCT05918510
Condition:
Squamous Cell Carcinoma of the Oropharynx
Carcinomas of Unknown Primary Site
High-risk Human Papillomavirus Infection
Liquid Biopsy
Lymph Node Metastasis
Occult Tumor of the Head and Neck Area
Conditions: Official terms:
Papillomavirus Infections
Carcinoma
Papilloma
Lymphatic Metastasis
Head and Neck Neoplasms
Conditions: Keywords:
Oropharyngeal Tumor
Occult Cancer
HPV Infection
head-neck area
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
Description:
The prospective observational study involves the collection of tissue, blood and saliva
samples from OPSCC and occult T patients for detection of HPV-DNA/RNA, miRNA and mutation
profile from DNA with centralized analysis of samples at IRCCS Regina Elena National
Cancer Institute.
Arm group label:
Group 1
Arm group label:
Group 2
Summary:
Based on the evidence summarized in the introduction, the clinician hypothesize that the
detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain
mutational profile in the tissues and biological fluids of these patients, may have
important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+
occult T. Accordingly, this study aims to aim to better characterize their potential as
biomarkers and to detect the possibility of their their use to implement the sensitivity
and specificity of radiological methodologies (PET-CT and MRI), already in use in
clinical practice, for monitoring disease progression in this specific subgroup. Finally,
by using the collected material to generate organoids and Patient Derived Xenograft
(PDX), the study also aims to identify possible new molecular drugs, which could solve
the problem of resistance to radiochemotherapy.
Criteria for eligibility:
Study pop:
Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node
metastases Cytologically positive laterocervical squamous cell carcinoma treated with
TORS or RT or RT/CT
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node
metastases laterocervical cytologically positive for squamous cell carcinoma treated
with TORS or RT or RT/CT
- Age > 18 years
- ECOG performance status <_ 2
- Ability to follow study procedures and complete questionnaires
- Signature of informed consent
Exclusion Criteria:
- Presence of distant metastases at the time of diagnosis
- Previous cancer of the head and neck district
- Second tumor in therapy or follow-up for less than 5 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Raul Pellini, MD
Phone:
ND
Email:
raul.pellini@ifo.it
Start date:
April 4, 2022
Completion date:
April 4, 2029
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Collaborator:
Agency:
Istituto Europeo di Oncologia
Agency class:
Other
Collaborator:
Agency:
Azienda Policlinico Umberto I
Agency class:
Other
Collaborator:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
University of Firenze and Siena, Napoli, Italy
Agency class:
Other
Collaborator:
Agency:
Weizmann Institute of Science
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/NCT05918510
