ClinicalTrials.gov record NCT06205953
A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
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)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A prospective patient registry that enrolls people with newly diagnosed AL amyloidosis at participating referral centers and satellite sites. It pairs a clinical database with a cross-border biorepository and shared sample network. The study plans to enroll about 400 patients at diagnosis to link molecular findings with outcomes.
What it is studying. The study is collecting clinical information and stored biosamples to learn how detailed molecular and genetic data relate to diagnosis, disease course, and outcomes in AL amyloidosis, and to test advanced methods for detecting very small amounts of disease after treatment (minimal residual disease).
What the researchers hope to learn. Define how advanced molecular technologies can support earlier diagnosis and inform treatment choices; describe the contemporary natural history of AL amyloidosis in a representative cohort; investigate and refine sensitive technologies to detect minimal residual disease after hematologic complete response.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- non-AL amyloidosis;
- previous treatment for AL amyloidosis.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are enrolled at diagnosis and followed over time (outcomes include mortality at 24 months and disease relapse by 2 years). They will provide clinical information and biological samples into a cross‑border biorepository and sample‑sharing network for advanced molecular analysis and big‑data studies. Samples and data will be used by the consortium for research, including studies of residual disease (minimal residual disease) and molecular profiling. Participation requires attending the participating center for planned follow‑up visits and consenting to sample storage and analysis.
How the study is structured. A prospective observational registry: newly diagnosed patients are enrolled at participating centers, their clinical data are recorded over time, and biosamples are stored and shared for advanced molecular testing and centralized big-data analysis.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany, Italy, Netherlands, Spain, Switzerland, Uruguay. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Jan 1, 2024
- Primary completion
- Jun 1, 2026 (estimated)
- Study completion
- Jun 1, 2026 (estimated)
- Target enrollment
- 400 participants (estimated)
- Last updated on registry
- Apr 16, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Principal investigator
- Giovanni Palladini, MD, PhD
Fondazione IRCCS Policlinico San Matteo di Pavia
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Giovanni Palladini 📞 +390382502994 ✉ segreteria.amiloidosi@smatteo.pv.it
Participating sites (6)
- Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672Recruiting
Heidelberg · Germany
- Stefan Schönland, MD
- Stefan Schönland, MD
- Ute Hegenbart, MD
- Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100Recruiting
Pavia · Italy
- Giovanni Palladini
- Giovanni Palladini, MD, PhD
- Mario Ulisse Nuvolone, MD, PhD
- UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, HeidelberglaanRecruiting
Utrecht · Netherlands
- Monique Minnema, MD
- Monique Minnema, MD
- Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, NavarraRecruiting
Pamplona · Spain
- Bruno Paiva, PhD
- Bruno Paiva, PhD
- University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical InformaticsActive Not Recruiting
Muttenz · Switzerland
- Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"Recruiting
Montevideo · Uruguay
- Eloisa Riva, MD · +59819534637 · eriva@hc.edu.uy
- Eloisa Riva, MD
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- treatment-naïve
- Has not previously received the treatment, or the type of treatment, that the study is about.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biorepository
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- minimal residual disease
- Very small amounts of disease that remain after treatment and can only be found with highly sensitive tests. 'MRD-negative' means none was detected at the test's limit. The exact test and threshold depend on the condition and the study.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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