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NCT07512921Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
27 Mar 2026
Start date
18 Feb 2025
Primary completion date
31 Jul 2027
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT number
NCT07512921

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 18 Feb 2025 to the primary completion date, 31 Jul 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Insufficient data about previous medical history.

Other illness

  • 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)
  • Sinonasal/paranasal cancers

Other

  • Recurrent/metastatic HNSCC
  • p16+ oropharyngeal squamous cell carcinoma
  • Skin squamous cell carcinoma from the skin of the head and neck
  • Nasopharyngeal carcinoma

Who the study is looking for

  • 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.-

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliera Universitaria di Sassari
Coordinator of this site? Confirm its status
SassariItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.