Clinical trial NCT06205953: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AL Amyloidosis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 patients with AL amyloidosis will be enrolled at diagnosis and evaluated at any of the participating clinical centers.

Brief 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.

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).

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.

Primary outcomes:
measure: Mortality at 24 months by stage
timeFrame: 24 months from diagnosis
Secondary outcomes:
measure: Rate of hematologic relapse in Complete Response patients at 2 years by MRD status
timeFrame: 2 years from diagnosis
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100
city: Utrecht
country: Netherlands
facility: UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan
city: Pamplona
country: Spain
facility: Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra
city: Muttenz
country: Switzerland
facility: University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics
city: Montevideo
country: Uruguay
facility: Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"
Study officials:
References: