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Merged with other trial
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| Name | Class |
|---|---|
| Flemish institute of biotechnology (VIB) | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry | Other | observational data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Participant baseline demographics | Demographic characteristics of amyloidosis participants will be assessed at baseline. | Baseline |
| Participant amyloidosis diagnosis information | Disease characteristics will be collected at moment of diagnosis. | Baseline |
| Sequence of treatments in participants with amyloidosis | Treatment sequences for participants with amyloidosis within routine clinical care will be assessed. | From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response | Documentation of response rates per line of treatment. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants for the study are newly diagnosed amyloidosis patients and amyloidosis patients in follow up at UZ Leuven Gasthuisberg at moment of EC approval.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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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.
| 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. | 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). | 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). | From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |