Head and Neck (HNSCC)BIOMATCHNCT07512921
Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers
An observational study of Head and Neck (HNSCC), run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial summary
The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck (HNSCC)
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Feb 2025to 31 Dec 2027
- 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: Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.
Who may be able to join
- Pathologic diagnosis of HNSCC
- Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx
- Stage III-IVa/b according to the eighth edition of AJCC/UICC classification
- Treatment with curative intent
- Unequivocal clinical and/or radiological absence of metastatic disease
- Patient ability and availability to comply with study protocol procedures.-
Who cannot join
- Recurrent/metastatic HNSCC
- p16+ oropharyngeal squamous cell carcinoma
- Evidence of high-risk HPV infection at tumor level
- Cancer of unknown primary site
- Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)
- Skin squamous cell carcinoma from the skin of the head and neck
Show all 9Show fewer
- Nasopharyngeal carcinoma
- Sinonasal/paranasal cancers
- Insufficient data about previous medical history.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Stefano Cavalieri contact
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Lisa Licitra, +39 02 2390 2810, lisa.licitra@istitutotumori.mi.it
- Recruiting
Azienda Ospedaliera Universitaria di Sassari
Sassari
Francesco Bussu, +39 079 264 4509, fbussu@uniss.it
About this study
Official title: Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers (BIOMATCH - Head and Neck)
The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Today, these types can only be found by studying tumor tissue. This study wants to see if a simple blood sample can give the same information.
The main questions the study aims to answer are:
Read more
- Can a blood test identify the same tumor type that researchers find by studying tumor tissue under a microscope and through genetic testing?
- Can these blood test results help predict how people may do after finishing treatment?
Researchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.
Participants will:
- Give a blood sample before starting treatment.
- Give another blood sample about 3 months after finishing treatment.
- Allow researchers to use a sample of their tumor (already collected as part of standard care) for genetic testing.
- Continue routine follow-up visits with their care team.
About 300 adults with locally advanced, HPV-negative head and neck cancer (affecting the mouth, throat, voice box, or hypopharynx) will take part. Only people who are receiving treatment to cure their cancer can join. People with returning cancer or cancer that has already spread cannot join.
Researchers will study:
- Gene activity in tumor tissue
- Gene activity in blood
- Patterns in blood fragments and small molecules
- Digital images of tumor samples using computer-based tools
The study will compare these different types of information to see whether a blood test can reliably show the tumor's biological type. If it can, this could make it easier to monitor the cancer after treatment and may help guide future care.
This study does not test any new drug or treatment. It collects information that may help improve care for people with HPV-negative head and neck cancer in the future.
- Conditions
- Head and Neck (HNSCC)
- Being tested
- Standard of Care (Investigator Choice)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (Investigator Choice)Other
This study does not include any medical treatment or experimental therapy. The only study-specific procedures are the collection and analysis of biological samples.
The intervention consists of:
- Two blood draws: one before the start of routine cancer treatment and one about 3 months after treatment is completed.
- Use of stored tumor tissue collected previously as part of standard medical care.
- Laboratory analyses of these samples to study gene activity, DNA fragments, DNA methylation, and circulating microRNAs.
- Digital analysis of tumor slides using computer-based tools to identify biological patterns.
These procedures are used only to compare blood-based markers with tumor-based markers. They do not change or influence the participant's medical treatment, which is decided entirely by their usual care team.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients.
AUROC (area under receiver operating characteristics) of b-OMICS (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent.
Measured: 6 months
Secondary outcomes (2)
OS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Overall survival (OS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).
Measured: 6 months
DFS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Disease-free survival (DFS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start18 Feb 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (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 (HNSCC)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Sassari, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Pineta Grande Hospital, Castel Volturno (CE), Italy, Istituto Europeo di Oncologia, San Raffaele University Hospital, Italy
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512921
- Sponsor's protocol ID
- INT137-24
- Acronym
- BIOMATCH
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers (BIOMATCH - Head and Neck)
- ClinicalTrials.gov ID
- NCT07512921
- Acronym / sponsor ID
- BIOMATCH / INT137-24
- Conditions
- Head and Neck (HNSCC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Sassari, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Pineta Grande Hospital, Castel Volturno (CE), Italy, Istituto Europeo di Oncologia, San Raffaele University Hospital, Italy
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Apr 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.
The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Today, these types can only be found by studying tumor tissue. This study wants to see if a simple blood sample can give the same information.
The main questions the study aims to answer are:
- Can a blood test identify the same tumor type that researchers find by studying tumor tissue under a microscope and through genetic testing?
- Can these blood test results help predict how people may do after finishing treatment?
Researchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.
Participants will:
- Give a blood sample before starting treatment.
- Give another blood sample about 3 months after finishing treatment.
- Allow researchers to use a sample of their tumor (already collected as part of standard care) for genetic testing.
- Continue routine follow-up visits with their care team.
About 300 adults with locally advanced, HPV-negative head and neck cancer (affecting the mouth, throat, voice box, or hypopharynx) will take part. Only people who are receiving treatment to cure their cancer can join. People with returning cancer or cancer that has already spread cannot join.
Researchers will study:
- Gene activity in tumor tissue
- Gene activity in blood
- Patterns in blood fragments and small molecules
- Digital images of tumor samples using computer-based tools
The study will compare these different types of information to see whether a blood test can reliably show the tumor's biological type. If it can, this could make it easier to monitor the cancer after treatment and may help guide future care.
This study does not test any new drug or treatment. It collects information that may help improve care for people with HPV-negative head and neck cancer in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.
Key inclusion criteria (6 listed)
- Pathologic diagnosis of HNSCC
- Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx
- Stage III-IVa/b according to the eighth edition of AJCC/UICC classification
- Treatment with curative intent
- Unequivocal clinical and/or radiological absence of metastatic disease
Key exclusion criteria (9 listed)
- Recurrent/metastatic HNSCC
- p16+ oropharyngeal squamous cell carcinoma
- Evidence of high-risk HPV infection at tumor level
- Cancer of unknown primary site
- Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)
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 |
|---|---|---|
| Standard of Care (Investigator Choice)This study does not include any medical treatment or experimental therapy. The only study-specific procedures are the collection and analysis of biological samples. The intervention consists of: * Two blood draws: one before the start of routine cancer treatment and one about 3 months after treatment is completed. * Use of stored tumor tissue collected previously as part of standard medical care. * Laboratory analyses of these samples to study gene activity, DNA fragments, DNA methylation, and circulating microRNAs. * Digital analysis of tumor slides using computer-based tools to identify biological patterns. These procedures are used only to compare blood-based markers with tumor-based markers. They do not change or influence the participant's medical treatment, which is decided entirely by their usual care team. | Other | – |
Primary outcome
Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients.
Time frame: 6 months
AUROC (area under receiver operating characteristics) of b-OMICS (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent.
2 secondary outcomes
OS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Time frame: 6 months
DFS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Time frame: 6 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 6 Apr 2026.
- 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.
Stefano Cavalieri contact
Lisa Licitra principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites 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 (HNSCC), run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites 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 9 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lisa Licitra (+39 02 2390 2810, lisa.licitra@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients. (time frame: 6 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 6 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.