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| Name | Class |
|---|---|
| Azienda Ospedaliero Universitaria di Sassari | OTHER |
| Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale | NETWORK |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (Investigator Choice) | Other | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| DFS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Loco-regionally advanced HPV-unrelated HNSCC adult patients amenable to treatments with curative intent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Licitra | Contact | +39 02 2390 2810 | lisa.licitra@istitutotumori.mi.it | |
| Stefano Cavalieri | Contact | stefano.cavalieri@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Licitra | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Pineta Grande Hospital, Castel Volturno (CE), Italy | UNKNOWN |
| Istituto Europeo di Oncologia | OTHER |
| San Raffaele University Hospital, Italy | OTHER |
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The study will keep:
No additional procedures beyond routine tumor collection and two small blood draws are required to obtain these samples.
Disease-free survival (DFS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature). |
| 6 months |
| 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 | 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 | 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 | 6 months |
| DFS of HPV-negative HNSCC patients based on digital pathology model. | DFS stratified according to the newly developed digital pathology model. | 6 months |
| OS of HPV-negative HNSCC patients based on digital pathology model. | OS stratified according to the newly developed digital pathology model. | 6 months |
| Azienda Ospedaliera Universitaria di Sassari | Recruiting | Sassari | Italy |
|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |