AIOCC Italian Registry on Head and Neck Carcinomas

NCT06248944 | Recruiting DMC

• 1 other identifier: AIR Study
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• proportion of patients in the different stage of disease

  From the enrollment to the end of the study (5 years)

• treatment outcomes

  From the enrollment to the end of the study (5 years)

• patients and disease characteristics

  From the enrollment to the end of the study (5 years)

• benchmark values

  From the enrollment to the end of the study (5 years)

• healthcare resource

  From the enrollment to the end of the study (5 years)

Interventions

observational-retrospective and prospective OTHER

observational-retrospective and prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated or followed for Head and Neck cancer

You may qualify if:

• 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.
• 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.
• New patients managed by the HCP from 2021 onwards + patients managed by the HCP, in active follow-up at the hospital

You may not qualify if:

• \. Patients whose medical records are unavailable for review

Sponsors & Collaborators

• Italian Head&Neck Society: lead

Study Sites (7)

Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, Italy

RECRUITING

A.O.U. Careggi

Florence, Italy

RECRUITING

P.O. 'Vito Fazzi'

Lecce, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

RECRUITING

Fondazione CNAO

Pavia, Italy

RECRUITING

Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

Roma, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

RECRUITING

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: July 6, 2022
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)