AL AmyloidosisEUREKANCT06205953
A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
An observational study of AL Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 6 sites in 6 countries.
Trial summary
A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- AL Amyloidosis
- How many people
- 400 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 1 Jan 2024to 1 Jun 2026
- 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: 400 patients with AL amyloidosis will be enrolled at diagnosis and evaluated at any of the participating clinical centers.
Who may be able to join
- diagnosis of systemic AL amyloidosis;
- treatment-naïve;
- age ≥18 years;
- ability to understand and willingness to sign an informed consent;
- planned follow-up at participating center.
Who cannot join
- non-AL amyloidosis;
- previous treatment for AL amyloidosis.
Trial locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 6 countries
Germany1 site, 1 recruiting
- Recruiting
Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672
Heidelberg
Stefan Schönland, MD
Stefan Schönland, MD
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100
Pavia
Giovanni Palladini
Giovanni Palladini, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan
Utrecht
Monique Minnema, MD
Monique Minnema, MD
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra
Pamplona
Bruno Paiva, PhD
Bruno Paiva, PhD
Switzerland1 site
- Active, not recruiting
University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics
Muttenz
Uruguay1 site, 1 recruiting
- Recruiting
Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"
Montevideo
Eloisa Riva, MD, +59819534637, eriva@hc.edu.uy
Eloisa Riva, MD
About this study
Official title: Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.
Read the detailed description
In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).
- Conditions
- AL Amyloidosis
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 24 months by stage
Mortality at 24 months by stage will be evaluated
Measured: 24 months from diagnosis
Secondary outcomes (1)
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated
Measured: 2 years from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (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.
- 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
- 400 participants (estimated)
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
- NCT06205953
- Sponsor's protocol ID
- AC-021-EU
- Acronym
- EUREKA
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
- ClinicalTrials.gov ID
- NCT06205953
- Acronym / sponsor ID
- EUREKA / AC-021-EU
- Conditions
- AL Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jan 2024 (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.
A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.
Detailed description
In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 patients with AL amyloidosis will be enrolled at diagnosis and evaluated at any of the participating clinical centers.
Key inclusion criteria (5 listed)
- diagnosis of systemic AL amyloidosis;
- treatment-naïve;
- age ≥18 years;
- ability to understand and willingness to sign an informed consent;
- planned 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
Mortality at 24 months by stage
Time frame: 24 months from diagnosis
Mortality at 24 months by stage will be evaluated
1 secondary outcome
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status
Time frame: 2 years from diagnosis
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.
- Individual participant dataSharing planned: No
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AL Amyloidosis
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.
6 sites in 6 countries: 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 6 sites in 6 countries.
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 6 sites in Germany, Italy, Netherlands, Spain, Switzerland and 1 more country. 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?
Contact Giovanni Palladini (+390382502994, segreteria.amiloidosi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 24 months by stage (time frame: 24 months from diagnosis). 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.