Clinical trial NCT06248944: AIOCC Italian Registry on Head and Neck Carcinomas
Official title: AIOCC Italian Registry on Head and Neck Carcinomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Carcinoma
Lead sponsor: Italian Head&Neck Society
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated or followed for Head and Neck cancer

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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

Primary outcomes:
measure: types of diagnostic and treatment patterns
timeFrame: From the enrollment to the end of the study (5 years)
Secondary outcomes:
measure: proportion of patients in the different stage of disease
timeFrame: From the enrollment to the end of the study (5 years)
measure: treatment outcomes
timeFrame: From the enrollment to the end of the study (5 years)
measure: patients and disease characteristics
timeFrame: From the enrollment to the end of the study (5 years)
measure: benchmark values
timeFrame: From the enrollment to the end of the study (5 years)
measure: healthcare resource
timeFrame: From the enrollment to the end of the study (5 years)
measure: prognostic factors
timeFrame: From the enrollment to the end of the study (5 years)
measure: between differences in mortality and differences in medical practice
timeFrame: From the enrollment to the end of the study (5 years)
measure: potential benefit
timeFrame: From the enrollment to the end of the study (5 years)
measure: immunization
timeFrame: From the enrollment to the end of the study (5 years)
measure: econometric approach
timeFrame: From the enrollment to the end of the study (5 years)
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - IRCCS
city: Firenze
country: Italy
facility: A.O.U. Careggi
city: Lecce
country: Italy
facility: P.O. 'Vito Fazzi'
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Pavia
country: Italy
facility: Fondazione CNAO
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
Study officials:
References: