A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06205953

Studienbeginn:
Januar 2024

Letztes Update:
19.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Immunoglobulin Light-chain Amyloidosis, Amyloidosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
IRCCS Policlinico S. Matteo

Collaborator:
-

Kontakt

Giovanni Palladini
Kontakt:
Phone: +390382502994
E-Mail: segreteria.amiloidosi@smatteo.pv.it» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672
Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stefan Schönland, MD» Ansprechpartner anzeigen

Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100
Pavia
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giovanni Palladini» Ansprechpartner anzeigen

UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan
Utrecht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Monique Minnema, MD» Ansprechpartner anzeigen

Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra
Pamplona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Bruno Paiva, PhD» Ansprechpartner anzeigen

University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics
Muttenz
SwitzerlandAktiv, nicht rekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Mortality at 24 months by stage (Time Frame - 24 months from diagnosis):
Mortality at 24 months by stage will be evaluated

Secondary outcome:

1. Rate of hematologic relapse in Complete Response patients at 2 years by MRD status (Time Frame - 2 years from diagnosis):
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated

Quelle: ClinicalTrials.gov

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