Squamous Cell Carcinoma of OropharynxNCT06821243
Patients With Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
An observational study of Squamous Cell Carcinoma of Oropharynx, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Oropharynx
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2024to 24 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by oropharynx squamous cell carcinoma (OPSCC) in head and neck district
Who may be able to join
- Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
- Age > 18 years
- ECOG performance status <_ 2
- Signature of informed consent (to participate in the study and data processing)
Who cannot join
- Presence of distant metastases at the time of diagnosis
- Previous head and neck cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS National Cancer Institute "Regina Elena"
Rome, Rome, 00144
Antonello Vidiri, Medical Doctor, +39 0652665071 ext. +39, antonello.vidiri@ifo.it
About this study
Official title: Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response
Read the detailed description
The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.
- Conditions
- Squamous Cell Carcinoma of Oropharynx
- Keywords
- carcinoma of the oropharynx, squamous cell carcinoma of the oropharynx, head and neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe the kinetics of HPV-DNA levels circulating in the blood
ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.
Measured: 24 months
Secondary outcomes (2)
Immuno-phenotyping at the tissue and blood level
Immuno-phenotyping at the tissue and blood level will be performed. Specific T cells for HPV will be identified by detecting the expression of the induced marker by activation (AIM) on the cell surface or by the production of intracellular cytokines, after exposure to HPV-derived peptide pools. AIM+ CD4+ T cells will be defined as positive for the expression of CD40L and CD69, while the expression of CD137 and CD69 will identify the subgroup CD8+ AIM+. The frequency and absolute number of specific CD4+ and CD8+ T cells will be determined HPV. Precise immunophenotyping will be performed using two panels antibodies. Innate immune cells and B lymphocytes will be investigated using a panel specific antibody to obtain a complete view of the patients' immune system
Measured: 24 months
Isolation of extracellular vesicles
Extracellular vesicles will be isolated from patient plasma using Size exclusion chromatography to obtain homogeneous samples in terms of size using qEV35 columns, then stored in pre-filtered PBS at +4°C and used within 48 hours. Nanoparticle Tracking Analysis (NTA) will be used to determine the concentration and the size of vesicles isolated using Nanosight NS300. Membrane markers small EVs will be analyzed using the MACSPLex Human Exosomes kit (Milteny Biotec), for detection of 37 different membrane epitopes and two control isotypes.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start24 Jul 2024
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of OropharynxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, Federico II University, I.R.C.C.S. Fondazione Santa Lucia, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821243
- Sponsor's protocol ID
- RS193/IRE/24
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
- ClinicalTrials.gov ID
- NCT06821243
- Acronym / sponsor ID
- RS193/IRE/24
- Conditions
- Squamous Cell Carcinoma of Oropharynx
- Keywords
- carcinoma of the oropharynx, squamous cell carcinoma of the oropharynx, head and neck
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, Federico II University, I.R.C.C.S. Fondazione Santa Lucia, Italy
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response
Detailed description
The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by oropharynx squamous cell carcinoma (OPSCC) in head and neck district
Key inclusion criteria (4 listed)
- Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
- Age > 18 years
- ECOG performance status <_ 2
- Signature of informed consent (to participate in the study and data processing)
Key exclusion criteria (2 listed)
- Presence of distant metastases at the time of diagnosis
- Previous head and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observe the kinetics of HPV-DNA levels circulating in the blood
Time frame: 24 months
ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.
2 secondary outcomes
Immuno-phenotyping at the tissue and blood level
Time frame: 24 months
Isolation of extracellular vesicles
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of Oropharynx, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonello Vidiri, Medical Doctor (+39 0652665071 ext. +39, antonello.vidiri@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the kinetics of HPV-DNA levels circulating in the blood (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.