AL AmyloidosisReALNCT04839003
A Registry of AL Amyloidosis (ReAL)
An observational study of AL Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The purpose of this protocol is to generate a large registry of patients with AL amyloidosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- AL Amyloidosis
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2020to May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes.
Who may be able to join
- 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.
Who cannot join
- non-AL amyloidosis;
- previous treatment for AL amyloidosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Giovanni Palladini, MD, +390382502994, giovanni.palladini@unipv.it
About this study
Official title: A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.
Read the 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
- Keywords
- amyloidosis, prognosis, registry
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a registry of patients with AL amyloidosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start27 Feb 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Palladini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839003
- Sponsor's protocol ID
- AC-018-IT
- Acronym
- ReAL
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
- ClinicalTrials.gov ID
- NCT04839003
- Acronym / sponsor ID
- ReAL / AC-018-IT
- Conditions
- AL Amyloidosis
- Keywords
- amyloidosis, prognosis, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- non-AL amyloidosis;
- previous treatment for AL amyloidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a registry of patients with AL amyloidosis
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AL Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a registry of patients with AL amyloidosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.