Squamous Cell Carcinoma of the OropharynxNCT05918510
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
An observational study of Squamous Cell Carcinoma of the Oropharynx and Carcinomas of Unknown Primary Site, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx, Carcinomas of Unknown Primary Site, High-risk Human Papillomavirus Infection
- What is being tested?
- Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2022to 4 Apr 2029
- 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: 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
Who may be able to join
- 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
Who cannot join
- 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
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
"Regina Elena" National Cancer Institute
Rome, 00144
Raul Pellini, MD, ND, raul.pellini@ifo.it
About this study
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.
- Conditions
- 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
- Being tested
- Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
- Keywords
- Oropharyngeal Tumor, Occult Cancer, HPV Infection, head-neck area
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lymphatic Metastasis, Oropharyngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of Viral BIOmarkers and microRNAs in Tumors OrofarynxDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | High miR value Receives: Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx | |
| Group 2 | Control group Receives: Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accouracy
Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start4 Apr 2022
- Primary completion4 Apr 2024 (estimated)
- Study completion4 Apr 2029 (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 the 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituto Europeo di Oncologia, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Firenze and Siena, Napoli, Italy, Weizmann Institute of Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918510
- Sponsor's protocol ID
- RS1647/22
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
- ClinicalTrials.gov ID
- NCT05918510
- Acronym / sponsor ID
- RS1647/22
- Conditions
- 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
- Keywords
- Oropharyngeal Tumor, Occult Cancer, HPV Infection, head-neck area
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituto Europeo di Oncologia, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Firenze and Siena, Napoli, Italy, Weizmann Institute of Science
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 4 Apr 2024 (estimated)
- Study completion
- 4 Apr 2029 (estimated)
- First posted
- 26 Jun 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors OrofarynxHigh miR value |
| Group 2 | – | Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors OrofarynxControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study of Viral BIOmarkers and microRNAs in Tumors OrofarynxThe 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. | Diagnostic test | Group 1, Group 2 |
Primary outcome
Accouracy
Time frame: Baseline
Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.
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 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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 the Oropharynx and Carcinomas of Unknown Primary Site, 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 5 inclusion and 3 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 10 Oct 2023. 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 Raul Pellini, Doctor (06-52664484, raul.pellini@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accouracy (time frame: Baseline). 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 10 Oct 2023.