Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205953
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-01-04
Brief Title:
A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis EUREKA
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUREKA
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 cellslight chains in patients achieving a complete hematologic response to therapy minimal residual disease MRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None