An observational study in Head and Neck (HNSCC), sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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:
Researchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.
Participants will:
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:
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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
DFS of HPV-negative HNSCC patients based on digital pathology model.
DFS stratified according to the newly developed digital pathology model.
Time frame: 6 months
OS of HPV-negative HNSCC patients based on digital pathology model.
OS stratified according to the newly developed digital pathology model.
Time frame: 6 months
Plan to share: Undecided
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