AIOCC Italian Registry on Head and Neck Carcinomas

Recruiting

• Conditions: Head and Neck Carcinoma

• Registration Number: NCT06248944
• Lead Sponsor: Italian Head&Neck Society

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.

Study Timeline

• Study Start: 2022-07-06
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2027-07-06
• Study Completion: 2027-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
types of diagnostic and treatment patterns	From the enrollment to the end of the study (5 years)	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.

Secondary Outcome Measures

Name	Time	Method
patients and disease characteristics	From the enrollment to the end of the study (5 years)	To describe patients and disease characteristics (considering possibility of familiar occurrence).
healthcare resource	From the enrollment to the end of the study (5 years)	To evaluate healthcare resource utilization in the total population
treatment outcomes	From the enrollment to the end of the study (5 years)	To assess treatment outcomes in all patients by stage of disease
benchmark values	From the enrollment to the end of the study (5 years)	To find benchmark values for selected indicators (i.e., number of retrieved nodes, surgical complication, etc.) for surgical treatment
potential benefit	From the enrollment to the end of the study (5 years)	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
between differences in mortality and differences in medical practice	From the enrollment to the end of the study (5 years)	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)
immunization	From the enrollment to the end of the study (5 years)	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
econometric approach	From the enrollment to the end of the study (5 years)	To assess the links between costs and health outcomes using an econometric approach, taking into account confounding factors (stage, performance status, comorbidities, etc.).
proportion of patients in the different stage of disease	From the enrollment to the end of the study (5 years)	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.
prognostic factors	From the enrollment to the end of the study (5 years)	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

Trial Locations

Locations (7)

A.O.U. Careggi; 🇮🇹 Firenze, Italy

P.O. 'Vito Fazzi'; 🇮🇹 Lecce, Italy

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milano, Italy

Fondazione del Piemonte per l'Oncologia - IRCCS; 🇮🇹 Candiolo, Italy

Fondazione CNAO; 🇮🇹 Pavia, Italy

Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, Italy