AIOCC Italian Registry on Head and Neck Carcinomas

Head and Neck Carcinoma Clinical Trial

Official title:

AIOCC Italian Registry on Head and Neck Carcinomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248944
• Other study ID #: AIR Study
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: July 6, 2027

Study information

• Verified date: March 2024
• Source: Italian Head&Neck Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: July 6, 2027
• Est. primary completion date: July 6, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Carcinoma

Intervention

Other:
• observational-retrospective and prospective
observational-retrospective and prospective

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia - IRCCS	Candiolo
Italy	A.O.U. Careggi	Firenze
Italy	P.O. 'Vito Fazzi'	Lecce
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano
Italy	Fondazione CNAO	Pavia
Italy	Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS	Roma
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Italian Head&Neck Society

Country where clinical trial is conducted

Italy, 

Outcome

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