Amyloidosis
Conditions
Brief summary
The goal of this observational study is to establish database with (limited) personal and health data of patients diagnosed with amyloidosis (any subtype) in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.
Detailed description
With the support of VIB 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. In this context, a registry of clinical data is a requirement for both improvement of diagnostics as well as fundamental research purposes.
Interventions
OTHERRegistry
observational data collection
Sponsors
Vlaams Instituut voor Biotechnologie
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Provide consent and sign informed consent form * Confirmed diagnosis of amyloidosis (any subtype), systemic and/or localised * Newly diagnosed or in follow-up during the study time-frame (1 JUN 2025 until 31 DEC 2027)
Exclusion criteria
* Not able to provide informed consent * Not willing to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant baseline demographics | Baseline | Demographic characteristics of amyloidosis participants will be assessed at baseline. |
| Participant amyloidosis diagnosis information | Baseline | Disease characteristics will be collected at moment of diagnosis. |
| Sequence of treatments in participants with amyloidosis | From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years | Treatment sequences for participants with amyloidosis within routine clinical care will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | Documentation of response rates per line of treatment. |
| 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 | 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). |
| 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 | 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 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 | TTNT is defined as the time from the date of initiation of regimen to the initiation of next regimen for each successive therapy received. |
Countries
Belgium
Outcome results
None listed