A Registry of AL Amyloidosis (ReAL)

AL Amyloidosis Clinical Trial

— ReAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839003
• Other study ID #: AC-018-IT
• Status: Recruiting
• Start date: February 27, 2020
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a registry of patients with AL amyloidosis		5 years