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Trial Title:
AIOCC Italian Registry on Head and Neck Carcinomas
NCT ID:
NCT06248944
Condition:
Head and Neck Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
observational-retrospective and prospective
Description:
observational-retrospective and prospective
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.
Criteria for eligibility:
Study pop:
Patients treated or followed for Head and Neck cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Fondazione del Piemonte per l'Oncologia - IRCCS
Address:
City:
Candiolo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vanesa Gregorc
Phone:
0119933811
Email:
vanesa.gregorc@ircc.it
Facility:
Name:
A.O.U. Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lorenzo Livi
Phone:
0557947264
Email:
lorenzo.livi@unifi.it
Facility:
Name:
P.O. 'Vito Fazzi'
Address:
City:
Lecce
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa Cavalera
Phone:
0832661174
Email:
cav.eli@libero.it
Facility:
Name:
Fondazione IRCCS Istituto Nazionale Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lisa Licitra
Phone:
+390223902150
Email:
lisa.licitra@istitutotumori.mi.it
Facility:
Name:
Fondazione CNAO
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ester Orlandi
Phone:
0382078407
Email:
orlandi@cnao.it
Facility:
Name:
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Almadori
Phone:
0630154439
Email:
giovanni.almadori@policlinicogemelli.it
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata di Verona
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Sacchetto
Phone:
0458128333
Email:
luca.sacchetto@aovr.veneto.it
Start date:
July 6, 2022
Completion date:
July 6, 2027
Lead sponsor:
Agency:
Italian Head&Neck Society
Agency class:
Other
Source:
Italian Head&Neck Society
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248944
