A Registry of AL Amyloidosis (ReAL)

NCT ID: NCT04839003

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2025-05-31

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.

Conditions

AL Amyloidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Palladini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanni Palladini, MD

Role: primary

giovanni.palladini@unipv.it

+390382502994

Other Identifiers

AC-018-IT

Identifier Type: -

Identifier Source: org_study_id