Matching tumor and blood gene tests for HPV-negative head and neck cancer

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

This project will try to see if a simple blood test can show the same tumor gene patterns as tissue samples in people with HPV-negative head and neck cancer.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Academic / other)
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT07512921 on ClinicalTrials.gov

What this trial studies

This is an observational study that collects blood samples and compares gene expression patterns in blood with those found in matched primary tumor tissue from people with HPV-negative squamous head and neck cancers. Participants give a blood sample before starting curative-intent treatment and another about three months after finishing treatment while they receive standard care from their own clinical team. Researchers will analyze whether blood-based gene signatures correspond to tumor subtypes and whether those signatures relate to clinical outcomes. The study is conducted at specialized cancer centers in Italy and enrolls patients with stage III–IVa/b, non-metastatic, p16/HPV-negative primary tumors of selected head and neck sites.

Who should consider this trial

Good fit: Ideal candidates are adults with a pathologic diagnosis of primary, HPV-negative (p16-negative) squamous cell carcinoma of the oral cavity, p16-negative oropharynx, hypopharynx, or larynx, stage III–IVa/b, planned for curative-intent treatment and without metastatic disease.

Not a fit: Patients with p16-positive oropharyngeal cancer, recurrent or metastatic disease, non-squamous head and neck cancers (for example salivary gland tumors, lymphoma, sarcoma, melanoma), nasopharyngeal or sinonasal cancers, or skin-origin head and neck squamous cell carcinoma are not likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a blood test could provide the same tumor subtype information without invasive biopsy, helping predict outcomes and potentially guiding follow-up or treatment decisions.

How similar studies have performed: Other liquid biopsy research has shown promise detecting tumor DNA/RNA and some blood-based signatures have correlated with tumor biology, but directly matching whole tumor gene expression from blood in HPV-negative head and neck cancer remains preliminary.

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.

Where this trial is running

Milan and 1 other locations

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

Study contacts

• Principal investigator: Lisa Licitra — Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
• Study coordinator: Lisa Licitra

Conditions Head and Neck