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.
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
Recurrent/metastatic HNSCC
p16+ oropharyngeal squamous cell carcinoma
Evidence of high-risk HPV infection at tumor level
Cancer of unknown primary site
Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.
Cohort
Prospective
Standard of Care (Investigator Choice)
Other interventionThis 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.
Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients.
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.
OS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Overall survival (OS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).
DFS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.
Disease-free survival (DFS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).
Sensitivity of a blood GE profile (b-OMICS) in identifying the digital pathology model in loco-regionally advanced HPV-negative HNSCC patients
Sensitivity of b-OMICS (newly identified and developed in the current project) in diagnosing the digital pathology model (newly identified and developed in the current project) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent
Specificity of a blood GE profile (b-OMICS) in identifying the digital pathology model in loco-regionally advanced HPV-negative HNSCC patients
Specificity of b-OMICS (newly identified and developed in the current project) in diagnosing the digital pathology model (newly identified and developed in the current project) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent
Sensitivity of a digital pathology model in identifying the t-OMICS in loco-regionally advanced HPV-negative HNSCC patients
Sensitivity of digital pathology model (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
Specificity of a digital pathology model in identifying the t-OMICS in loco-regionally advanced HPV-negative HNSCC patients
Specificity of digital pathology model (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
Click on the lead sponsor to view all of their trials.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Azienda Ospedaliero Universitaria di Sassari
Collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Pineta Grande Hospital, Castel Volturno (CE), Italy
Collaborator
Istituto Europeo di Oncologia
Collaborator
San Raffaele University Hospital, Italy
Collaborator
