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ClinicalTrials.gov ID

NCT06248944

Lead Sponsor

Italian Head&Neck SocietyOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

7,000Estimated

Last Update Posted

Mar 8, 2024Actual

Start Date

Jul 6, 2022Actual

Primary Completion Date

Jul 6, 2027Estimated

Completion Date

Jul 6, 2027Estimated

Official Title

AIOCC Italian Registry on Head and Neck Carcinomas

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.

• Head and Neck Carcinoma

• observational-retrospective and prospective

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

Eligibility Criteria

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

Observational Model

Other

Time Perspective

Other

Lead Sponsor

Italian Head&Neck SocietyOTHER

orlandi@cnao.it0382078407