Head and Neck TumorsNCT06224166
Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence
An observational study of Head and Neck Tumors, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Tumors
- What is being tested?
- Collection and use of tissue samples, blood and saliva
- How many people
- 283 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 17 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 suffering from head and neck tumors, recruited in a manner consecutive among those who underwent surgery at the ENT UOC of the IRE between January 2019 and December 2021 and for which, at the start of the study, archive samples as well as i follow-up data up to at least one year after surgery. The biological samples of the cohort selected include both fresh tissue and liquid biopsy (blood and saliva) samples.
Who may be able to join
- Age over 18 years
- Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx
- Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
- Availability of material (tissue) and follow-up data for at least one year (retrospective part)
- Written informed consent (prospective part/patients in follow-up
Who cannot join
- Presence of distant metastases at the time of diagnosis
- Previous head and neck cancer+
- Second cancer under treatment or follow-up for less than 5 years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Giovanni Blandino, Doctor, 06 52662911, giovanni.blandino@ifo.it
About this study
Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.
Read the detailed description
For each patient they will come collected tissue, blood and saliva samples. In particular, as regards tissue collection, tumor and neighboring tissues will be used healthy specimens taken during surgical removal, according to clinical practice.
The fresh tissues thus collected will be stored in RNA-later before freezing at - 80°C.
Furthermore, blood and saliva samples will be taken at different times, in particular:
- the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the patient's follow-up (FU): every 3 months for the first 2 years and every 6 months for the following 3 years.
The samples will then be used to carry out nucleic acid extraction, the DNA will instead be used to detect the presence of HPV.
- Conditions
- Head and Neck Tumors
- Being tested
- Collection and use of tissue samples, blood and saliva
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection and use of tissue samples, blood and salivaDiagnostic test
For tissue collection, tumor and surrounding tissues will be used healthy specimens taken during surgical removal, according to clinical practice. Blood and saliva sampling will be carried out at different times:
- the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the follow-up (FU)
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarkers
The samples that will be collected in this study will be used to carry out nucleic acid extraction.
In particular, the extraction of RNA and DNA from tissue samples will be carried out using the "All prep RNA/DNA miRNA universal kit" kit (Qiagen), while from blood and saliva samples it will be carried out respectively through the use of the "DNAeasy blood and tissue kit" (Qiagen) and the "Magmax Total RNA extraction kit" (Thermofisher), following the instructions given in the relevant protocol.
The expression of tissue and circulating microRNAs will be evaluated by qRT-PCR analysis using the Taqman method (Life Technology), digital-PCR (dPCR) and Luminex platform (the latter at the IRCSS G Paolo II Tumor Institute of Bari). In particular, the use of dPCR will be necessary for those low-abundance circulating miRNAs which, with the qRT-PCR methodology, are not detectable.
Measured: 24 months
Secondary outcomes (2)
Evaluate HPV-DNA expression as biomarkers.
The DNA will be used to detect the presence of HPV and will be analyzed using dPCR and the Luminex platform. These methods are able to absolutely quantify the number of viral genomes present in the sample and also to evaluate the physical state of the virus: episomal, integrated or mixed..
Measured: 24 months
Evaluate miRNA expression as biomarkers
To identify the prognostic role of the 4 miRNAs in the liquid biopsy, the analysis of the expression of the same miRNAs in the tissue component, in order to evaluate their possible correlation.
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 posted25 Jan 2024
- Study start17 Jan 2023
- Primary completion17 Jan 2025 (estimated)
- Study completion17 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorsStudies 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
- Other
- Enrolment
- 283 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Istituti Tumori Giovanni Paolo II
- Responsible party
- Sponsor
- Investigators
- Giovanni Blandino, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224166
- Sponsor's protocol ID
- RS1826/23
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence
- ClinicalTrials.gov ID
- NCT06224166
- Acronym / sponsor ID
- RS1826/23
- Conditions
- Head and Neck Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 283 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Milan, Istituti Tumori Giovanni Paolo II
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jan 2025 (estimated)
- Study completion
- 17 Jan 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.
Detailed description
For each patient they will come collected tissue, blood and saliva samples. In particular, as regards tissue collection, tumor and neighboring tissues will be used healthy specimens taken during surgical removal, according to clinical practice.
The fresh tissues thus collected will be stored in RNA-later before freezing at - 80°C.
Furthermore, blood and saliva samples will be taken at different times, in particular:
- the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the patient's follow-up (FU): every 3 months for the first 2 years and every 6 months for the following 3 years.
The samples will then be used to carry out nucleic acid extraction, the DNA will instead be used to detect the presence of HPV.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from head and neck tumors, recruited in a manner consecutive among those who underwent surgery at the ENT UOC of the IRE between January 2019 and December 2021 and for which, at the start of the study, archive samples as well as i follow-up data up to at least one year after surgery. The biological samples of the cohort selected include both fresh tissue and liquid biopsy (blood and saliva) samples.
Key inclusion criteria (5 listed)
- Age over 18 years
- Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx
- Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
- Availability of material (tissue) and follow-up data for at least one year (retrospective part)
- Written informed consent (prospective part/patients in follow-up
Key exclusion criteria (3 listed)
- Presence of distant metastases at the time of diagnosis
- Previous head and neck cancer+
- Second cancer under treatment 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 |
|---|---|---|
| Collection and use of tissue samples, blood and salivaFor tissue collection, tumor and surrounding tissues will be used healthy specimens taken during surgical removal, according to clinical practice. Blood and saliva sampling will be carried out at different times: i) the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the follow-up (FU) | Diagnostic test | – |
Primary outcome
Identification of biomarkers
Time frame: 24 months
The samples that will be collected in this study will be used to carry out nucleic acid extraction. In particular, the extraction of RNA and DNA from tissue samples will be carried out using the "All prep RNA/DNA miRNA universal kit" kit (Qiagen), while from blood and saliva samples it will be carried out respectively through the use of the "DNAeasy blood and tissue kit" (Qiagen) and the "Magmax Total RNA extraction kit" (Thermofisher), following the instructions given in the relevant protocol. The expression of tissue and circulating microRNAs will be evaluated by qRT-PCR analysis using the Taqman method (Life Technology), digital-PCR (dPCR) and Luminex platform (the latter at the IRCSS G Paolo II Tumor Institute of Bari). In particular, the use of dPCR will be necessary for those low-abundance circulating miRNAs which, with the qRT-PCR methodology, are not detectable.
2 secondary outcomes
Evaluate HPV-DNA expression as biomarkers.
Time frame: 24 months
Evaluate miRNA expression as biomarkers
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Related trials for Head and Neck Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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. This study is not recruiting at the moment.
Giovanni Blandino, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
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 Head and Neck Tumors, 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Blandino, Doctor (06 52662911 ext. +39, giovanni.blandino@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biomarkers (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 26 Jan 2024.