BE.Amycon Biobank & Data Registry UZ Leuven
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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".
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Not willing to sign informed consent
Not able to sign informed consent
Trial population
Patients diagnosed with amyloidosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Establishment of a data registry: participant baseline demographics
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Time frame
Baseline2
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
Baseline3
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 years4
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 yearsSecondary outcomes
1
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 years2
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.3
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.4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Flemish institute of biotechnology (VIB)
Collaborator
Source ClinicalTrials.gov