AIOCC Italian Registry on Head and Neck Carcinomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational-retrospective and prospective.
- Who it may be relevant to
- Registry conditions: Head and Neck Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other observational-retrospective and prospective
observational-retrospective and prospective
Primary outcome measures
- types of diagnostic and treatment patterns [Time frame: From the enrollment to the end of the study (5 years)]
Secondary outcome measures (10)
- proportion of patients in the different stage of disease [Time frame: From the enrollment to the end of the study (5 years)]
- treatment outcomes [Time frame: From the enrollment to the end of the study (5 years)]
- patients and disease characteristics [Time frame: From the enrollment to the end of the study (5 years)]
- benchmark values [Time frame: From the enrollment to the end of the study (5 years)]
- healthcare resource [Time frame: From the enrollment to the end of the study (5 years)]
- prognostic factors [Time frame: From the enrollment to the end of the study (5 years)]
- between differences in mortality and differences in medical practice [Time frame: From the enrollment to the end of the study (5 years)]
- potential benefit [Time frame: From the enrollment to the end of the study (5 years)]
- immunization [Time frame: From the enrollment to the end of the study (5 years)]
- econometric approach [Time frame: From the enrollment to the end of the study (5 years)]
Eligibility criteria
Inclusion criteria
- Adult patients (age ≥ 18 years old) diagnosed with carcinoma of the Head and Neck. The diagnosis should be done or verified by the expert site entering the information about the patient in the registry. Patients diagnosed with sarcomas and lymphomas are excluded.
- Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP will collect information on the entire disease regardless of when it started to manage the patient. The HCP can choose, based on its resources, for how many patients will be able to collect the data.
- New patients managed by the HCP from 2021 onwards + patients managed by the HCP, in active follow-up at the hospital
Exclusion criteria
1\. Patients whose medical records are unavailable for review
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Italy · 7 centers
- Fondazione del Piemonte per l'Oncologia - IRCCS — Candiolo
- A.O.U. Careggi — Florence
- P.O. 'Vito Fazzi' — Lecce
- Fondazione IRCCS Istituto Nazionale Tumori — Milan
- Fondazione CNAO — Pavia
- Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS — Roma
- Azienda Ospedaliera Universitaria Integrata di Verona — Verona
Identifiers
NCT: NCT06248944 · AIR Study