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

Official title

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

Overview

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.

Interventions

• Other 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

Primary outcome measures

• 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]

Secondary outcome measures (2)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 2 centers

• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
• Azienda Ospedaliera Universitaria di Sassari — Sassari

Identifiers

NCT: NCT07512921 · INT137-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗