An observational study in Amyloidosis, AL Amyloidosis and Amyloidosis Cardiac, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
The goal of this study is to collect and store human body material (HBM) of patients with amyloidosis in a biobank "BE.Amycon biobank" for future research and to collect clinical data of patients with amyloidosis in a database "BE.Amycon data registry".
With the support of VIB (Vlaams Instituut voor Biotechnologie) Grand Challenges Program, this project aims to establish the BElgian AMYloidosis CONsortium (BE.AMYCON) by joining forces of VIB researchers, a state-of-the-art diagnostic platform, and clinicians from various disciplines and different institutes. Such a consortium will address patient needs and improve outcomes on many levels.
The aim is is to establish a GDPR (General Data Protection Regulation)-proof HBM biobank in the context of amyloidosis. HBM of patients with suspected or confirmed amyloidosis will be prospectively collected and stored for future scientific research. In addition to the HBM collection, a database with personal and health data of patients diagnosed with amyloidosis (any subtype) will be established in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.
239 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 63 are open to participants now.
This study's planned enrollment of 505 is above the median of 275 across 42 observational studies indexed under Immunoglobulin Light-chain Amyloidosis.
Browse Immunoglobulin Light-chain Amyloidosis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Immunoglobulin Light-chain Amyloidosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Amyloidosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients diagnosed with amyloidosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Establishment of a data registry: participant baseline demographics
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Time frame: Baseline
Establishment of a data registry: description of the disease characteristics of patients with amyloidosis at diagnosis
Disease characteristics of amyloidosis (disease presentation and symptoms, type of organ involvment, results of diagnostic tests (lab values, imaging, biopsy)) will be collected at moment of diagnosis.
Time frame: Baseline
Establishment of a data registry: treatment in participants with amyloidosis
Description of treatment (type of treatment per line of treatment) of participants with amyloidosis within routine clinical care.
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Establishment of a biobank with biological samples (blood, urine, tissue) from patients with amyloidosis
Biological samples (blood, urine, tissue) will be collected from patients with amyloidosis.
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 2 years
Best Response
Documentation of response rates per line of treatment
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Duration of response
Duration of response is defined as the time from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.
Time to Next Treatment (TTNT)
TTNT is defined as the time from the date of initiation of regimen to the initiation of next regimen for each successive therapy received.
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.
Overall Survival (OS)
OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Progression-free survival (PFS)
PFS is defined as the time from the date of initiation of therapy to the date of progression or death of any cause, whichever occurs first (or last documented follow-up).
Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Plan to share: Yes — IPD will be available upon signed MTA and DTA and approval by steering committee meeting and ethics committee.
Time frame: Per approved user protocol
Access criteria: upon signed MTA and DTA and approval by steering committee meeting and ethics committee
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2029, 48 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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