Lung Diseases Clinical Trial
— BioMaroteauxOfficial title:
Biomarker for Maroteaux-Lamy Disease: BioMaroteaux-Lamy AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
Verified date | February 2023 |
Source | CENTOGENE GmbH Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Development of a new MS-based biomarker for the early and sensitive diagnosis of Maroteaux-Lamy disease from blood
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months and older |
Eligibility | Inclusion Criteria: - Informed consent will be obtained from the patient or the parents before any study related procedures. - Patients older than 12 months - The patient has a diagnosis of Maroteaux-Lamy disease Exclusion Criteria: - No Informed consent from the patient or the parents before any study related procedures - Patients younger than 12 months - The patient has no diagnosis of Maroteaux-Lamy disease |
Country | Name | City | State |
---|---|---|---|
Egypt | Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo | |
Germany | Centogene AG | Rostock | |
India | Amrita Institute of Medical Sciences & Research Centre | Cochin | Kerala |
India | Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN) | Mumbai | |
Sri Lanka | Lady Ridgeway Hospital for Children | Colombo 8 |
Lead Sponsor | Collaborator |
---|---|
CENTOGENE GmbH Rostock |
Egypt, Germany, India, Sri Lanka,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of a new MS-based biomarker for the early and sensitive diagnosis of Maroteaux-Lamy disease from blood (plasma) | New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity. | 24 month | |
Secondary | Testing for clinical robustness, specificity and long-term stability of the biomarker | the goal of the study to identify and validate a new biochemical marker from the blood of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment | 36 months |
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