Squamous Cell Tumors of the Head and Neck (HNSCC)SPARNCT07471009
Development of Patient Derived Xenografts (PDXs) and Analysis of Tyrosine Kinase Receptor Expression in Patients With Squamous Cell Head and Neck Cancer (HNSCC) to Study Resistance Mechanisms Induced by Standard Therapy
An observational study of Squamous Cell Tumors of the Head and Neck (HNSCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Protocol TitleDevelopment of Patient-Derived Xenografts (PDXs) and analysis of tyrosine kinase receptor expression in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) to study resistance mechanisms induced by standard therapy (SPAR).Brief SummaryThe SPAR study aims to better understand why some patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Tumors of the Head and Neck (HNSCC)
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2026to 1 Oct 2032
- 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
- Adult, Older adult
Study population: The SPAR study will involve approximately 120 patients with head and neck squamous cell carcinoma (HNSCC). The retrospective phase will analyze tissue samples (FFPE) from about 40 patients treated with cetuximab over the last 10 years at the IRCCS in Bologna, regardless of their disease stage. The prospective phase will enroll 80 surgical candidates over the next 5 years, collecting samples during standard clinical care to develop PDX models and perform molecular analysis. For both groups, clinical, demographic, and outcome data will be collected following the acquisition of informed consent.
Who may be able to join
- Patients aged 18 years or older at the time of tissue collection
- Obtaining written informed consent
- For patients enrolled retrospectively:
- 1. Patients with squamous cell carcinoma of the head and neck treated by the Medical Oncology Unit because they underwent medical treatment with cetuximab in the last 10 years following histological diagnosis carried out in the Otolaryngology or Maxillofacial Surgery Units
- For prospectively enrolled patients:
- 1. Patients with squamous cell carcinoma of the head and neck who will be recruited over the next 5 years
Who cannot join
- For patients enrolled retrospectively:
- Patients with material that is qualitatively and/or quantitatively unsuitable for the necessary immunohistochemical and molecular investigations.
- For patients enrolled prospectively: None, except for diagnoses other than squamous cell carcinoma.
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
IRCSS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Mattia Lauriola, biologist, 051 20 9 4118, mattia.lauriola2@unibo.it
About this study
Protocol TitleDevelopment of Patient-Derived Xenografts (PDXs) and analysis of tyrosine kinase receptor expression in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) to study resistance mechanisms induced by standard therapy (SPAR).Brief SummaryThe SPAR study aims to better understand why some patients with head and neck squamous cell carcinoma (HNSCC) stop responding to standard treatments. Researchers will create a specialized set of "Patient-Derived Xenografts" (PDXs)-biological models developed by grafting fresh human tumor samples into immunocompromised mice.By analyzing these models alongside historical patient samples, the study will investigate the expression of various protein receptors (such as the ERBB family, MET, and AXL) and their signaling pathways. The goal is to identify alternative therapeutic targets that could allow the use of existing drugs approved for other cancers, providing new hope for patients with drug-resistant HNSCC.Study DesignStudy Type: Combined Prospective and Retrospective observational/translational study.Prospective Phase: Over 5 years, researchers will collect fresh tumor and blood samples from patients undergoing surgery. These samples will be used to develop the PDX models and undergo genetic and molecular characterization (NGS, IHC, WB).Retrospective Phase: Researchers will analyze archived biological materials (FFPE samples) from patients treated over the last 10 years to evaluate molecular markers and resistance pathways.Duration: 6.5 years total (5 years for enrollment, 1.5 years for data analysis).Participant PopulationTotal Enrollment: 120 patients.Retrospective Group (approx. 40 cases): Patients with HNSCC treated with Cetuximab in the last 10 years.Prospective Group (80 cases): Patients with HNSCC scheduled for surgery at the IRCCS Policlino S. Orsola in Bologna.Eligibility CriteriaInclusion Criteria:Age $\ge$ 18 years at the time of tissue collection.Signed informed consent.Confirmed histological diagnosis of squamous cell carcinoma of the head and neck.For the retrospective group: Prior treatment with Cetuximab.For the prospective group: Candidates for surgery within the Otorhinolaryngology or Maxillofacial units.Exclusion Criteria:Retrospective: Biological material of insufficient quality or quantity for immunohistochemical/molecular analysis.Prospective: Any diagnosis other than squamous cell carcinoma.Outcome Measures / MethodologyThe study will utilize advanced molecular techniques to map the tumor landscape, including:Genomic/Transcriptomic Analysis: Next-Generation Sequencing (NGS), qPCR, and ddPCR to identify mutations and gene rearrangements.Protein Expression: ELISA, Immunohistochemistry (IHC), Immunoblotting, and QF-Pro/PLA technology to evaluate receptor activity.Virology: Identification of HPV presence and genotypes.
Read the detailed description
- Protocol Identification \& Administrative StatusStudy Acronym: SPAR Protocol Date: 04-02-2026 Version: 3 (Superseding version 1 from 26/11/2025) Study Duration: 6.5 years total (5 years enrollment/selection, 8-12 months for PDX expansion, 3 months molecular analysis, 2 months data analysis) Principal Investigator: Mattia Lauriola Coordinating Institution: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Policlinico S. Orsola) 2. Scientific Background \& RationaleHead and Neck Squamous Cell Carcinoma (HNSCC) remains a global health challenge, representing the seventh most common cancer with approximately 890,000 new cases and 450,000 deaths annually.The Resistance ProblemWhile standard therapies include surgery, chemotherapy, and radiation, recent innovations like PD-1 inhibitors (pembrolizumab, nivolumab) benefit only 20-30% of patients. Cetuximab (CTX), an anti-EGFR monoclonal antibody, is a standard treatment, but acquired resistance is a frequent barrier.The Biological HypothesisResistance is often driven by:RTK Bypass: Activation of alternative receptor tyrosine kinases (RTKs) such as MET, AXL, IGFR1, and MERTK.ERBB Family Interactions: The ERBB family (EGFR, HER2, HER3, HER4) utilizes complex heterodimerization to maintain signaling despite EGFR inhibition.Signaling Pathways: Downstream activation of RAS and PI3K/AKT pathways, as well as alterations in the tumor microenvironment (e.g., cytokines, EMT markers).The SPAR project aims to address this by developing unique Italian Patient-Derived Xenograft (PDX) models to study these specific resistance mechanisms.3. Study Objectives \& OutcomesPrimary ObjectiveGoal: To develop a set of HNSCC PDX models.Method: Implantation of surgical tumor samples into immunocompromised mice.Assessment: Success is evaluated 2-3 months post-implantation.Secondary ObjectivesMolecular Characterization: Comprehensive analysis of RTK expression (EGFR, HER2, HER3, HER4, MET, AXL, IGFR1, MERTK) and their ligands (e.g., NRG1-4, EGF, HGF).Technological Scope: Utilize NGS (genomic and transcriptomic), RT-qPCR, ddPCR, ELISA, Western Blot, and QF-Pro Technology to map the tumor landscape.Virology: Detection of HPV genotypes and presence of viral oncogene transcripts (E6).4. Study Design \& MethodologyThis is a non-profit, observational, cross-sectional study using both retrospective and prospective cohorts.Retrospective Phase (n = 40)Sample Source: Archived FFPE (formalin-fixed paraffin-embedded) materials from the last 10 years at IRCCS AOU Bologna.Population: Patients treated with Cetuximab (both locally advanced and R/M settings).Inclusion: Patients must have adequate biological material for immunohistochemical/molecular analysis.Prospective Phase (n = 80)Duration: Enrollment over 5 years.Source: Patients undergoing surgery for HNSCC at IRCCS S. Orsola.PDX Development: Fresh tumor/blood samples collected during standard care.Feasibility: Researchers estimate a 30% success rate for PDX development, targeting sufficient models for a robust biobank.5. Clinical Procedures \& Data ManagementClinical EvaluationThis study does not introduce experimental pharmacological treatments; it aligns with the patient's "usual care".Patients in therapy are seen every 2-3 weeks; patients not in active therapy are followed up every 3 months for the first 2 years, then every 6 months for the next 3 years.Data GovernancePlatform: Data is recorded in a pseudonymized electronic Case Report Form (eCRF) using the REDCap platform.Personnel: The Principal Investigator maintains a delegation log for data management duties.Statistical Analysis: Conducted using GraphPad Prism (v.9.5.0). Demographics are reported as frequencies (categorical) or mean/median (continuous).6. Ethics \& Regulatory ComplianceInformed ConsentWritten informed consent is mandatory for participation.Special Case (Deceased/Unreachable Patients): For the retrospective cohort, if patients are deceased or unreachable despite reasonable efforts, researchers may proceed without explicit consent under Art. 110, D.Lgs 196/2003, provided they comply with the Italian Data Protection Authority's requirements.Insurance \& AmendmentsAs an observational study, no study-specific insurance is required.Any protocol changes must be submitted to the Ethics Committee as formal amendments.7. Dissemination \& ReproducibilityOpen Science: The study will be registered on platforms such as clinicaltrials.gov or osf.io.Publication: The investigator commits to submitting findings to a peer-reviewed journal within 12 months of study conclusion, regardless of the results.Data Sharing: Anonymous data will be made available only after publication
- Keywords
- tumors
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a set of HNSCC PDX from patients diagnosed with squamous cell carcinoma of the head and neck
Measured: baseline
Secondary outcomes (1)
Expression of tumor markers, tyrosine kinase receptors, and their ligands both on fresh samples (prospective study) and on those present in the archive (retrospective 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 posted13 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Tumors of the Head and Neck (HNSCC)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471009
- Sponsor's protocol ID
- SPAR
- Acronym
- SPAR
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Patient Derived Xenografts (PDXs) and Analysis of Tyrosine Kinase Receptor Expression in Patients With Squamous Cell Head and Neck Cancer (HNSCC) to Study Resistance Mechanisms Induced by Standard Therapy
- ClinicalTrials.gov ID
- NCT07471009
- Acronym / sponsor ID
- SPAR / SPAR
- Keywords
- tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 13 Mar 2026 (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.
Protocol TitleDevelopment of Patient-Derived Xenografts (PDXs) and analysis of tyrosine kinase receptor expression in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) to study resistance mechanisms induced by standard therapy (SPAR).Brief SummaryThe SPAR study aims to better understand why some patients with head and neck squamous cell carcinoma (HNSCC) stop responding to standard treatments. Researchers will create a specialized set of "Patient-Derived Xenografts" (PDXs)-biological models developed by grafting fresh human tumor samples into immunocompromised mice.By analyzing these models alongside historical patient samples, the study will investigate the expression of various protein receptors (such as the ERBB family, MET, and AXL) and their signaling pathways. The goal is to identify alternative therapeutic targets that could allow the use of existing drugs approved for other cancers, providing new hope for patients with drug-resistant HNSCC.Study DesignStudy Type: Combined Prospective and Retrospective observational/translational study.Prospective Phase: Over 5 years, researchers will collect fresh tumor and blood samples from patients undergoing surgery. These samples will be used to develop the PDX models and undergo genetic and molecular characterization (NGS, IHC, WB).Retrospective Phase: Researchers will analyze archived biological materials (FFPE samples) from patients treated over the last 10 years to evaluate molecular markers and resistance pathways.Duration: 6.5 years total (5 years for enrollment, 1.5 years for data analysis).Participant PopulationTotal Enrollment: 120 patients.Retrospective Group (approx. 40 cases): Patients with HNSCC treated with Cetuximab in the last 10 years.Prospective Group (80 cases): Patients with HNSCC scheduled for surgery at the IRCCS Policlino S. Orsola in Bologna.Eligibility CriteriaInclusion Criteria:Age $\ge$ 18 years at the time of tissue collection.Signed informed consent.Confirmed histological diagnosis of squamous cell carcinoma of the head and neck.For the retrospective group: Prior treatment with Cetuximab.For the prospective group: Candidates for surgery within the Otorhinolaryngology or Maxillofacial units.Exclusion Criteria:Retrospective: Biological material of insufficient quality or quantity for immunohistochemical/molecular analysis.Prospective: Any diagnosis other than squamous cell carcinoma.Outcome Measures / MethodologyThe study will utilize advanced molecular techniques to map the tumor landscape, including:Genomic/Transcriptomic Analysis: Next-Generation Sequencing (NGS), qPCR, and ddPCR to identify mutations and gene rearrangements.Protein Expression: ELISA, Immunohistochemistry (IHC), Immunoblotting, and QF-Pro/PLA technology to evaluate receptor activity.Virology: Identification of HPV presence and genotypes.
Detailed description
- Protocol Identification \& Administrative StatusStudy Acronym: SPAR Protocol Date: 04-02-2026 Version: 3 (Superseding version 1 from 26/11/2025) Study Duration: 6.5 years total (5 years enrollment/selection, 8-12 months for PDX expansion, 3 months molecular analysis, 2 months data analysis) Principal Investigator: Mattia Lauriola Coordinating Institution: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Policlinico S. Orsola) 2. Scientific Background \& RationaleHead and Neck Squamous Cell Carcinoma (HNSCC) remains a global health challenge, representing the seventh most common cancer with approximately 890,000 new cases and 450,000 deaths annually.The Resistance ProblemWhile standard therapies include surgery, chemotherapy, and radiation, recent innovations like PD-1 inhibitors (pembrolizumab, nivolumab) benefit only 20-30% of patients. Cetuximab (CTX), an anti-EGFR monoclonal antibody, is a standard treatment, but acquired resistance is a frequent barrier.The Biological HypothesisResistance is often driven by:RTK Bypass: Activation of alternative receptor tyrosine kinases (RTKs) such as MET, AXL, IGFR1, and MERTK.ERBB Family Interactions: The ERBB family (EGFR, HER2, HER3, HER4) utilizes complex heterodimerization to maintain signaling despite EGFR inhibition.Signaling Pathways: Downstream activation of RAS and PI3K/AKT pathways, as well as alterations in the tumor microenvironment (e.g., cytokines, EMT markers).The SPAR project aims to address this by developing unique Italian Patient-Derived Xenograft (PDX) models to study these specific resistance mechanisms.3. Study Objectives \& OutcomesPrimary ObjectiveGoal: To develop a set of HNSCC PDX models.Method: Implantation of surgical tumor samples into immunocompromised mice.Assessment: Success is evaluated 2-3 months post-implantation.Secondary ObjectivesMolecular Characterization: Comprehensive analysis of RTK expression (EGFR, HER2, HER3, HER4, MET, AXL, IGFR1, MERTK) and their ligands (e.g., NRG1-4, EGF, HGF).Technological Scope: Utilize NGS (genomic and transcriptomic), RT-qPCR, ddPCR, ELISA, Western Blot, and QF-Pro Technology to map the tumor landscape.Virology: Detection of HPV genotypes and presence of viral oncogene transcripts (E6).4. Study Design \& MethodologyThis is a non-profit, observational, cross-sectional study using both retrospective and prospective cohorts.Retrospective Phase (n = 40)Sample Source: Archived FFPE (formalin-fixed paraffin-embedded) materials from the last 10 years at IRCCS AOU Bologna.Population: Patients treated with Cetuximab (both locally advanced and R/M settings).Inclusion: Patients must have adequate biological material for immunohistochemical/molecular analysis.Prospective Phase (n = 80)Duration: Enrollment over 5 years.Source: Patients undergoing surgery for HNSCC at IRCCS S. Orsola.PDX Development: Fresh tumor/blood samples collected during standard care.Feasibility: Researchers estimate a 30% success rate for PDX development, targeting sufficient models for a robust biobank.5. Clinical Procedures \& Data ManagementClinical EvaluationThis study does not introduce experimental pharmacological treatments; it aligns with the patient's "usual care".Patients in therapy are seen every 2-3 weeks; patients not in active therapy are followed up every 3 months for the first 2 years, then every 6 months for the next 3 years.Data GovernancePlatform: Data is recorded in a pseudonymized electronic Case Report Form (eCRF) using the REDCap platform.Personnel: The Principal Investigator maintains a delegation log for data management duties.Statistical Analysis: Conducted using GraphPad Prism (v.9.5.0). Demographics are reported as frequencies (categorical) or mean/median (continuous).6. Ethics \& Regulatory ComplianceInformed ConsentWritten informed consent is mandatory for participation.Special Case (Deceased/Unreachable Patients): For the retrospective cohort, if patients are deceased or unreachable despite reasonable efforts, researchers may proceed without explicit consent under Art. 110, D.Lgs 196/2003, provided they comply with the Italian Data Protection Authority's requirements.Insurance \& AmendmentsAs an observational study, no study-specific insurance is required.Any protocol changes must be submitted to the Ethics Committee as formal amendments.7. Dissemination \& ReproducibilityOpen Science: The study will be registered on platforms such as clinicaltrials.gov or osf.io.Publication: The investigator commits to submitting findings to a peer-reviewed journal within 12 months of study conclusion, regardless of the results.Data Sharing: Anonymous data will be made available only after publication
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The SPAR study will involve approximately 120 patients with head and neck squamous cell carcinoma (HNSCC). The retrospective phase will analyze tissue samples (FFPE) from about 40 patients treated with cetuximab over the last 10 years at the IRCCS in Bologna, regardless of their disease stage. The prospective phase will enroll 80 surgical candidates over the next 5 years, collecting samples during standard clinical care to develop PDX models and perform molecular analysis. For both groups, clinical, demographic, and outcome data will be collected following the acquisition of informed consent.
Key inclusion criteria (6 listed)
- Patients aged 18 years or older at the time of tissue collection
- Obtaining written informed consent
- 1. Patients with squamous cell carcinoma of the head and neck treated by the Medical Oncology Unit because they underwent medical treatment with cetuximab in the last 10 years following histological diagnosis carried out in the Otolaryngology or Maxillofacial Surgery Units
- 1. Patients with squamous cell carcinoma of the head and neck who will be recruited over the next 5 years
Key exclusion criteria (3 listed)
- For patients enrolled retrospectively:
- Patients with material that is qualitatively and/or quantitatively unsuitable for the necessary immunohistochemical and molecular investigations.
- For patients enrolled prospectively: None, except for diagnoses other than squamous cell carcinoma.
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
Development of a set of HNSCC PDX from patients diagnosed with squamous cell carcinoma of the head and neck
Time frame: baseline
1 secondary outcome
Expression of tumor markers, tyrosine kinase receptors, and their ligands both on fresh samples (prospective study) and on those present in the archive (retrospective study).
Time frame: baseline
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 13 Mar 2026.
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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 Tumors of the Head and Neck (HNSCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 6 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: opening soon, as of the sponsor's last update on 13 Mar 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 Mattia Lauriola, biologist (051 20 9 4118, mattia.lauriola2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a set of HNSCC PDX from patients diagnosed with squamous cell carcinoma of the head and neck (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 13 Mar 2026.