BE.Amycon Biobank & Data Registry UZ Leuven

NCT07172243 | Recruiting

• 1 other identifier: BE.AMYCON_UZL_WP2_02
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 2

Brief Summary

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".

Conditions

Amyloidosis; AL Amyloidosis; Amyloidosis Cardiac

Outcome Measures

Primary Outcomes (4)

• Establishment of a data registry: participant baseline demographics

  Demographic characteristics of amyloidosis participants will be assessed at baseline.

  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.

  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.

  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.

  From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 2 years

Secondary Outcomes (5)

• Best Response

  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

  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)

  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)

  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)

  From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with amyloidosis

You may qualify if:

• Provide consent and sign informed consent form
• Age 18 years or older
• Diagnosis of amyloidosis (suspected or confirmed, any subtypes)
• For the prospective sample collection only: newly diagnosed (any subtype) or at relapse (AL amyloidosis)

You may not qualify if:

• Not willing to sign informed consent
• Not able to sign informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vlaams Instituut voor Biotechnologie: collaborator

Study Sites (2)

UZ Leuven Gasthuisberg - hematology

Leuven, 3000, Belgium

RECRUITING

UZ Leuven Gasthuisberg - cardiology

Leuven, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, biopsy (in the context of amyloidosis), subcuteanous fat aspirate

MeSH Terms

Conditions

Amyloidosis; Immunoglobulin Light-chain Amyloidosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Study Officials

• Michel Delforge

  UZ Leuven Gasthuisberg

  PRINCIPAL INVESTIGATOR

• Joost Schymkowitz, Prof.

  VIB - Switch Lab

  PRINCIPAL INVESTIGATOR

• Frederic Rousseau, Prof.

  VIB - Switch Lab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Delforge

CONTACT

+32 16 346880; michel.delforge@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 15, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Per approved user protocol
• Access Criteria: upon signed MTA and DTA and approval by steering committee meeting and ethics committee

Locations

BE (2)