A Registry of AL Amyloidosis (ReAL)

Recruiting

• Conditions: AL Amyloidosis

• Registration Number: NCT04839003
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Study Timeline

• Study Start: 2020-02-27
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. diagnosis of systemic AL amyloidosis;
2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
3. age ≥18 years;
4. 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);
5. planned (or ongoing) follow-up at participating center.

Exclusion Criteria

1. non-AL amyloidosis;
2. previous treatment for AL amyloidosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creation of a registry of patients with AL amyloidosis	5 years

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy