AIOCC Italian Registry on Head and Neck Carcinomas

March 7, 2024 updated by: Italian Head&Neck Society
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Candiolo, Italy
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia - IRCCS
        • Contact:
      • Firenze, Italy
      • Lecce, Italy
        • Recruiting
        • P.O. 'Vito Fazzi'
        • Contact:
      • Milano, Italy, 20133
      • Pavia, Italy
        • Recruiting
        • Fondazione CNAO
        • Contact:
      • Roma, Italy
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Di Verona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients treated or followed for Head and Neck cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
types of diagnostic and treatment patterns
Time Frame: 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.
From the enrollment to the end of the study (5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients in the different stage of disease
Time Frame: 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.
From the enrollment to the end of the study (5 years)
treatment outcomes
Time Frame: From the enrollment to the end of the study (5 years)
To assess treatment outcomes in all patients by stage of disease
From the enrollment to the end of the study (5 years)
patients and disease characteristics
Time Frame: From the enrollment to the end of the study (5 years)
To describe patients and disease characteristics (considering possibility of familiar occurrence).
From the enrollment to the end of the study (5 years)
benchmark values
Time Frame: 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
From the enrollment to the end of the study (5 years)
healthcare resource
Time Frame: From the enrollment to the end of the study (5 years)
To evaluate healthcare resource utilization in the total population
From the enrollment to the end of the study (5 years)
prognostic factors
Time Frame: 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
From the enrollment to the end of the study (5 years)
between differences in mortality and differences in medical practice
Time Frame: 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)
From the enrollment to the end of the study (5 years)
potential benefit
Time Frame: 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
From the enrollment to the end of the study (5 years)
immunization
Time Frame: 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
From the enrollment to the end of the study (5 years)
econometric approach
Time Frame: 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.).
From the enrollment to the end of the study (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Head&Neck Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Estimated)

July 6, 2027

Study Completion (Estimated)

July 6, 2027

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIR Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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