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Recruiting NCT04839003

A Registry of AL Amyloidosis (ReAL)

Observational AL 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: AL 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

A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)

Overview

The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Detailed description

Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

Primary outcome measures

  • Creation of a registry of patients with AL amyloidosis [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • diagnosis of systemic AL amyloidosis;
  • treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
  • 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

  • non-AL amyloidosis;
  • previous treatment for 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 · 1 center
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT04839003 · AC-018-IT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗