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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 circulating microRNAs. * Digital analysis of tumor slides using computer-based tools to identify biological patterns. These procedures are used only to compare blood-based markers with tumor-based markers. They do not change or influence the participant's medical treatment, which is decided entirely by their usual care team.

Study 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

Primary outcome measure(s)

• Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients. — 6 months
  AUROC (area under receiver operating characteristics) of b-OMICS (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent.

Trial sites (2)

More Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials in Italy