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NAFLD Kohorte – Prospektive Kohorte und Biobank von Patienten mit nicht-alkoholischer Fettlebererkrankung (NAFLD Kohortenstudie)
Steckbrief
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).
Andere: Hepatology
Soziodemographie, Krankheit/ Diagnose, Intervention/Therapie
Aktiv, seit 2023
Nonalcoholic Fatty Liver Disease (NAFLD)
National, Currently, the cohort is single-center, with patients enrolled in Lugano at Epatocentro Ticino.
Andere: Fondazione Epatocentro Ticino
Privat
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
Nein
Nein
Nein
1h
Ja,
Nein
Ja
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.
Ja, Researchers may request data after approval by the study's scientific committee.
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.
Nein
Kontakt
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 ...
