BE.Amycon Biobank & Data Registry UZ Leuven
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyloidosis, AL Amyloidosis, Amyloidosis Cardiac. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis
Overview
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".
Detailed description
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.
Primary outcome measures
- Establishment of a data registry: participant baseline demographics [Time frame: Baseline]
- Establishment of a data registry: description of the disease characteristics of patients with amyloidosis at diagnosis [Time frame: Baseline]
- Establishment of a data registry: treatment in participants 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 10 years]
- Establishment of a biobank with biological samples (blood, urine, tissue) 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]
Secondary outcome measures (5)
- Best Response [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 [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) [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) [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) [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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Not willing to sign informed consent
- Not able to sign informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 2 centers
- UZ Leuven Gasthuisberg - hematology — Leuven
- UZ Leuven Gasthuisberg - cardiology — Leuven
Identifiers
NCT: NCT07172243 · BE.AMYCON_UZL_WP2_02