NCT06248944

AIOCC Italian Registry on Head and Neck Carcinomas

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,000 (estimated)
• Sponsor: Italian Head&Neck Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	observational-retrospective and prospective	observational-retrospective and prospective

Timeline

• Start date: 2022-07-06
• Primary completion: 2027-07-06
• Completion: 2027-07-06
• First posted: 2024-02-08
• Last updated: 2024-03-08

Locations

7 sites across 1 country: Italy