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Multicentre, retrospective and prospective observational study aimed to set-up a clinical Italian registry in order to collect information on carcinoma of the Head and Neck.
The registry plans to collect data on all patients treated or followed for Head and Neck cancer by the HCP of selected investigational sites in Italy.
Data will be entered manually by HCP staff of each investigational site in the study e-CRF in order to populate the AIR study database. Authorized HCPs will be provided with personal UserID and Password for the access to study eCRF.
For Data analysis an open-source system called Vantage6 will be used. It is a privacy preserving federated learning infrastructure for the secure exchange and analysis of incorporating data located at different sources. Queries will be issued to interrogate the database in order to have descriptive statistics and relevant information to plan the statistical analyses envisioned by the study protocol.
The registry data will support observational studies based on the second hand use of available data. Data collected for the AIR Study could be used also for global collaborative studies performed in Europe and outside the Europe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational-retrospective and prospective | Other | observational-retrospective and prospective |
| Measure | Description | Time Frame |
|---|---|---|
| types of diagnostic and treatment patterns | To document types of diagnostic and treatment patterns by all stages of disease and frequency, and proportion with which they are used in the different stages of Head and Neck cancer. | From the enrollment to the end of the study (5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients in the different stage of disease | To estimate the proportion of patients in the different stage of disease (TNM staging system 8^ edition) in the overall Head and Neck cancer patient population. | From the enrollment to the end of the study (5 years) |
| treatment outcomes |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients whose medical records are unavailable for review
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Patients treated or followed for Head and Neck cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia - IRCCS | Recruiting | Candiolo | Italy |
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| ID | Term |
|---|---|
| D008137 | Longitudinal Studies |
| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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To assess treatment outcomes in all patients by stage of disease |
| From the enrollment to the end of the study (5 years) |
| patients and disease characteristics | To describe patients and disease characteristics (considering possibility of familiar occurrence). | From the enrollment to the end of the study (5 years) |
| benchmark values | To find benchmark values for selected indicators (i.e., number of retrieved nodes, surgical complication, etc.) for surgical treatment | From the enrollment to the end of the study (5 years) |
| healthcare resource | To evaluate healthcare resource utilization in the total population | From the enrollment to the end of the study (5 years) |
| prognostic factors | To identify independent significant host-related prognostic factors and establish a more detailed prognostic classification for the growing population of Head and Neck cancer patients | From the enrollment to the end of the study (5 years) |
| between differences in mortality and differences in medical practice | To prove the relationship between differences in mortality and differences in medical practice or medical organizations (subspecialty of the surgeon; type of hospital; management in the cancer network; conformity with clinical practice guidelines) | From the enrollment to the end of the study (5 years) |
| potential benefit | To investigate the potential benefit for survival by classifying the detection of metastasis as early or late discoveries and by calculation of overall survival probabilities for both categories | From the enrollment to the end of the study (5 years) |
| immunization | To determine the influence of immunization with vaccines preceding the removal of the primary tumor on prognosis of Head and Neck cancer patients, adjusting for stage, primary site, age, sex, particular treatment methods or patterns of referral | From the enrollment to the end of the study (5 years) |
| econometric approach | To assess the links between costs and health outcomes using an econometric approach, taking into account confounding factors (stage, performance status, comorbidities, etc.). | From the enrollment to the end of the study (5 years) |
| A.O.U. Careggi | Recruiting | Florence | Italy |
|
| P.O. 'Vito Fazzi' | Recruiting | Lecce | Italy |
|
| Fondazione IRCCS Istituto Nazionale Tumori | Recruiting | Milan | 20133 | Italy |
|
| Fondazione CNAO | Recruiting | Pavia | Italy |
|
| Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS | Recruiting | Roma | Italy |
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| Azienda Ospedaliera Universitaria Integrata di Verona | Recruiting | Verona | Italy |
|
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |