A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AL Amyloidosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Netherlands, Spain, Switzerland +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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).
Primary outcome measures
- Mortality at 24 months by stage [Time frame: 24 months from diagnosis]
Secondary outcome measures (1)
- Rate of hematologic relapse in Complete Response patients at 2 years by MRD status [Time frame: 2 years from diagnosis]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672 — Heidelberg
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100 — Pavia
Netherlands · 1 center
- UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan — Utrecht
Spain · 1 center
- Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplo — Pamplona
Switzerland · 1 center
- University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Eng — Muttenz
Uruguay · 1 center
- Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela" — Montevideo
Identifiers
NCT: NCT06205953 · AC-021-EU