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| Name | Class |
|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
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The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.
The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | A total of 1000 SCCHN patients will be enrolled in a retrospective observational study treated in the period 2008-2014. Standard treatment of SCCHN patients The patients will be managed as foreseen by best clinical practice and international guidelines for SCCHN. |
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| Prospective cohort | A total of 450 SCCHN patients will be enrolled in a study. Each participating Center will select consecutive patients according to the selection criteria (inclusion/exclusion criteria) for one year and will be followed up for two years or more. Standard treatment of SCCHN patients: patients will be administered current best clinical practice treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment of SCCHN patients | Procedure | The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Realizes and validates an Integrated Decision Support System (BD2Decide platform) | The primary endpoint of this study is the accuracy of the prediction of prognosis based on the BD2Decide platform compared to Tumor Node Metastasis staging (in a population consisting of patients with different subtypes of head and neck cancer). | through study completion, an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Quality of Life | To measure patients' QoL in relation to the new prognostic stratification | baseline, month 6, month 18, month 24 after primary treatment |
| Assess survival time | Overall survival and disease free survival will be assessed to verify the accuracy of the prediction of BD2Decide platform |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective study cohort: A total of 450 SCCHN patients Stage III and IV, followed up for 18-24 months or more.
Retrospective study cohort: A total of 1000 SCCHN patients Stage III and IV, diagnosed between year 2008 and 2014.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tito Poli, MD, PhD | Contact | +39052170 | 3613 | tito.poli@unipr.it |
| Lisa Licitra, MD, PhD | Contact | +39 022390 | 2150 | lisa.licitra@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Tito Poli, MD, PHD | Azienda Ospedaliero-Universitaria di Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU | Recruiting | Düsseldorf | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40252811 | Derived | Cavalieri S, Brakenhoff RH, Leemans CR, Hoebers FJP, Poli T, Scheckenbach K, Iacovelli NA, Franceschini M, Orlandi E, Licitra L, De Cecco L. Prognostic gene expression signatures for HPV-negative head and neck squamous cell carcinoma. Radiother Oncol. 2025 Jul;208:110900. doi: 10.1016/j.radonc.2025.110900. Epub 2025 Apr 17. | |
| 34738049 |
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Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Maastricht Radiation Oncology |
| OTHER |
| Istituto Superiore di Sanità | OTHER |
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FFPE tumor specimens
| at 2, 3 and 5 years |
| Fondazione Irccs Istituto Dei Tumori Milano | Recruiting | Milan | MI | 20133 | Italy |
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| Azienda Ospedaliero Universitaria di Parma | Recruiting | Parma | PR | 43100 | Italy |
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| Stichting VU/VUmc | Active, not recruiting | Amsterdam | 1081 HV | Netherlands |
| Maastricht Radiation Oncology MAASTRO Clinic | Recruiting | Maastricht | 6229 ET | Netherlands |
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| Cavalieri S, Serafini MS, Carenzo A, Canevari S, Brakenhoff RH, Leemans CR, Nauta IH, Hoebers F, van den Hout MFCM, Scheckenbach K, Hoffmann TK, Ardighieri L, Poli T, Quattrone P, Locati LD, Licitra L, De Cecco L. Clinical Validity of a Prognostic Gene Expression Cluster-Based Model in Human Papillomavirus-Positive Oropharyngeal Carcinoma. JCO Precis Oncol. 2021 Oct 27;5:PO.21.00094. doi: 10.1200/PO.21.00094. eCollection 2021. |