NCT07512921 Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers
| NCT ID | NCT07512921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Head and Neck (HNSCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-02-18 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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.- Exclusion Criteria: * 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 * Nasopharyngeal carcinoma * Sinonasal/paranasal cancers * Insufficient data about previous medical history.
Contact & Investigator
Lisa Licitra
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Frequently Asked Questions
Who can join the NCT07512921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck (HNSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07512921 currently recruiting?
Yes, NCT07512921 is actively recruiting participants. Contact the research team at lisa.licitra@istitutotumori.mi.it for enrollment information.
Where is the NCT07512921 trial being conducted?
This trial is being conducted at Milan, Italy, Sassari, Italy.
Who is sponsoring the NCT07512921 clinical trial?
NCT07512921 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Lisa Licitra at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. The trial plans to enroll 300 participants.