Registry for patients with AL amyloidosis
A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
This study is collecting information from people with AL amyloidosis to better understand the disease and how it changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT04839003 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect comprehensive data from patients diagnosed with AL amyloidosis, both at the time of diagnosis and during follow-up. By gathering this information, researchers will be able to describe the natural history of the disease in a real-world context. The registry will also help in defining and validating prognostic models, as well as criteria for response and relapse throughout the course of the disease.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who have been diagnosed with systemic AL amyloidosis and are treatment-naïve.
Not a fit: Patients with non-AL amyloidosis or those who have previously received treatment for AL amyloidosis may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of AL amyloidosis and improve patient management through better prognostic models.
How similar studies have performed: While registries for other conditions have shown success in improving patient outcomes, this specific approach for AL amyloidosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.