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Recruiting NCT05444920

The Italian Transthyretin Amyloidosis Web-Network

Observational ATTR Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ATTR Amyloidosis. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)

Overview

The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.

Primary outcome measures

  • Establishing an online tool for data-sharing, available for health care providers [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Suspected diagnosis of systemic and localized amyloidosis;
  • age .18 years;
  • ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
  • planned (or ongoing) follow-up at participating center.

Exclusion criteria

1\. Diagnosis of light chain (AL) amyloidosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 30 centers
  • ASST Ovest Milanese - Ospedale di Legnano — Legnano
  • AOU San Luigi Gonzaga — Orbassano
  • AOU Ospedali Riuniti — Ancona
  • Policlinico di Bari — Bari
  • ASST Papa Giovanni XXIII — Bergamo
  • ASST Spedali Civili di Brescia — Brescia
  • Ospedale Oncologico "Armando Businco" — Cagliari
  • Azienda Ospedaliera di Cosenza — Cosenza
  • … and 22 more centers

Identifiers

NCT: NCT05444920 · AC-019-IT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗