AIOCC Italian Registry on Head and Neck Carcinomas

NCT ID: NCT06248944

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-06

Study Completion Date

2027-07-06

Brief Summary

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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

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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.

Conditions

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Head and Neck Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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observational-retrospective and prospective

observational-retrospective and prospective

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Head&Neck Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, , Italy

Site Status RECRUITING

A.O.U. Careggi

Florence, , Italy

Site Status RECRUITING

P.O. 'Vito Fazzi'

Lecce, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

Site Status RECRUITING

Fondazione CNAO

Pavia, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

Roma, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Vanesa Gregorc

Role: primary

0119933811

Lorenzo Livi

Role: primary

0557947264

Elisa Cavalera

Role: primary

0832661174

Lisa Licitra

Role: primary

+390223902150

Ester Orlandi

Role: primary

0382078407

Giovanni Almadori

Role: primary

0630154439

Luca Sacchetto

Role: primary

0458128333

Other Identifiers

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AIR Study

Identifier Type: -

Identifier Source: org_study_id

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