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.
Study Type
OBSERVATIONAL
Enrollment
505
UZ Leuven Gasthuisberg - hematology
Leuven, Belgium
RECRUITINGUZ Leuven Gasthuisberg - cardiology
Leuven, Belgium
RECRUITINGEstablishment 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.
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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