NCT04839003RecruitingNot Applicable
A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
Fondazione IRCCS Policlinico San Matteo di Pavia1 site in 1 country5,000 target enrollmentStarted: February 27, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- Creation of a registry of patients with AL amyloidosis
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Creation of a registry of patients with AL amyloidosis
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Giovanni Palladini
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Sites (1)
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