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NAFLD Kohorte – Prospektive Kohorte und Biobank von Patienten mit nicht-alkoholischer Fettlebererkrankung (NAFLD Kohortenstudie)

Steckbrief

Kurzbeschreibung

The NAFLD Cohort Study is a single-center, national, retrospective and prospective cohort aimed at collecting high-quality baseline and follow-up data on patients diagnosed with NAFLD, NASH, or MAFLD. The primary objective is to establish a unified cohort using standardized criteria to support future research into the clinical presentation, natural history, treatment response, genetic and metabolic risk factors, and overall disease outcomes. This cohort will facilitate the collection of clinical data and biological samples, enabling comprehensive studies on genetic, serological, microbiological, and immunological aspects of NAFLD/NASH/MAFLD. The project will provide a robust platform for investigating treatment options and patient responses over time. The cohort includes patients from Epatocentro Ticino and collaborating clinicians. Biological samples will be collected at different time-points and stored at -80°C. Clinical data, including patient demographics, comorbidities, and ongoing therapies, will be recorded using the REDCap® Database for Electronic Data Capture (EDC).

Fachrichtung

Andere: Hepatology

Registertyp

Klinisch

Datenarten

Soziodemographie,  Krankheit/ Diagnose,  Intervention/Therapie

Status

Aktiv, seit 2023

Population

Nonalcoholic Fatty Liver Disease (NAFLD)

Periodizität

Kontinuierlich

Geografische Abdeckung

National, Currently, the cohort is single-center, with patients enrolled in Lugano at Epatocentro Ticino.

Trägerschaft

Andere: Fondazione Epatocentro Ticino

Finanzierung

Privat

Betreiberinstitution

Fondazione Epatocentro Ticino
Via Soldino 9
6900 Lugano

Kontaktperson Andreas Cerny
E-Mail:
andreas.cerny
Tel.
0919106570
Website
https://www.epatocentro.ch/it/La-Fondazione

https://clinicaltrials.gov/stu... ...

Weitere Informationen

Schnittstellen

Anbindung an andere Register, Schnittstellen

Nein
 

Ist die Anbindung an ein anderes Register geplant?

Nein

 

Weitere Schnittstellen

Nein
 
 

Datenerfassung
In digitaler Form (Computer-unterstützte Dateneingabe), RedCap
 
In digitaler Form (Computer-unterstützte Dateneingabe)
 

1h
 

Teilnahmepflicht

Ja,
 

Teilnahmemöglichkeit

Nein
 

Einwilligung Patienten

Ja

Personenbezug

Anonymisiert (kein direkter Personenbezug möglich)

Datenschutz

Data generation, transmission, storage and analysis of health-related personal data and the storage of biological samples within this project will follow strictly the current Swiss legal requirements for data protection and will be performed according to the Ordinance HRO Art. 5. Project data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfil their duties within the scope of the research project. Password protection ensures that only authorized and trained staff can enter the eCRF system (REDCap®) to view, add or edit data according to their permissions. Such modifications will be visible in the audit trail. User training is performed by the CTU of Fondazione Epatocentro according to SOPs. Each enrolled patient is identified with a unique code. The code is assigned by the authorized personnel of Epatocentro Ticino (EPT) and managed by the CTU of Fondazione Epatocentro.  

Datenzugang

Ja, Researchers may request data after approval by the study's scientific committee.

Qualitätssicherung

The Data Manager of the CTU of Fondazione Epatocentro Ticino will enter the data from the project specific paper forms into an electronic data capture system (REDCap®). All the personnel involved in the project will be trained for their specific tasks and on all important project related aspects. Moreover, all team will follow the study-specific standard operating procedures (SOPs) guaranteeing the data and sample quality.  

Berichterstattung

Nein
 

Kontakt

Betreiberinstitution

Fondazione Epatocentro Ticino
Via Soldino 9
6900 Lugano

Kontaktperson Andreas Cerny
E-Mail:
andreas.cerny
Tel.
0919106570
Website
https://www.epatocentro.ch/it/La-Fondazione

https://clinicaltrials.gov/stu ...

Kontakt

FMH Generalsekretariat
Elfenstrasse 18, Postfach
CH-3000 Bern 16

Tel. 031 359 11 11
mail

Kontaktformular

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