Clinical trial · Observational
A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe
A Retrospective Observational Multicenter Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Group pre-2010
- description
- Patients who initiated first-line treatment between 2004 and 2010 (pre-2010).
- label
- Group post-2010
- description
- Patients who initiated first-line treatment between 2011 and 2018 (post-2010).
Primary outcomes (8)
- measure
- Patient and disease characteristics
- timeFrame
- 2004-2018
- description
- To describe the proportion of patients belonging to different age groups, and the proportion of patients per gender, stage, organ involvement, performance status, and hematologic biomarkers at screening or at baseline; by first-line treatment initiation period (pre-2010 or post-2010) and overall.
- measure
- Treatment patterns
- timeFrame
- 2004-2018
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 years * Confirmed diagnosis of AL-AMY and symptomatic organ involvement. * Initiated first line treatment for AL-AMY in the period 2004-2018. * Patients who have signed a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements. The inclusion of deceased subjects in the study is permitted under the condition that consent waiver has been granted by the Scientific Committee and/or Administrative Board of the participating sites and/or any applicable regulatory body, as per local regulations, to either implement a hospital informed consent form (ICF) already in place or provide written approval of this study-specific waiver. In the occasion that waiver of consent is not granted deceased subjects will not be enrolled in the study. Exclusion Criteria: * Patients under the age of 18 will not be considered eligible for this study
References
Publications (0)
Data not yet available