Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers

Recruiting now

Conditions studied: Head and Neck (HNSCC)

In brief

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.

Key facts

Study ID: NCT07512921
Run by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
People needed: 300
Starts: 2025-02-18
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.-

You may not qualify if…

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.

Where it is running

Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (enrolling)
Azienda Ospedaliera Universitaria di Sassari — Sassari, Italy (enrolling)

Full record on ClinicalTrials.gov

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