AIOCC Italian Registry on Head and Neck Carcinomas

Last updated: March 7, 2024
Sponsor: Italian Head&Neck Society
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

observational-retrospective and prospective

Clinical Study ID

NCT06248944
AIR Study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients (age ≥ 18 years old) diagnosed with carcinoma of the Head and Neck. Thediagnosis should be done or verified by the expert site entering the information aboutthe patient in the registry. Patients diagnosed with sarcomas and lymphomas areexcluded.
  2. Patients entering the HCP at any clinical phase of the disease (diagnosis, treatmentof primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP willcollect information on the entire disease regardless of when it started to manage thepatient. The HCP can choose, based on its resources, for how many patients will beable to collect the data.
  3. New patients managed by the HCP from 2021 onwards + patients managed by the HCP, inactive follow-up at the hospital

Exclusion

Exclusion Criteria:

  1. Patients whose medical records are unavailable for review

Study Design

Total Participants: 7000
Treatment Group(s): 1
Primary Treatment: observational-retrospective and prospective
Phase:
Study Start date:
July 06, 2022
Estimated Completion Date:
July 06, 2027

Study 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.

Connect with a study center

  • Fondazione del Piemonte per l'Oncologia - IRCCS

    Candiolo,
    Italy

    Active - Recruiting

  • A.O.U. Careggi

    Firenze,
    Italy

    Active - Recruiting

  • P.O. 'Vito Fazzi'

    Lecce,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Fondazione CNAO

    Pavia,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    Roma,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona,
    Italy

    Active - Recruiting

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