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WithdrawnNCT01457456BioMorquioUpdated Feb 13, 2023

Biomarker for Morquio Disease (BioMorquio)

An observational study in Morquio Syndrome, Accumulation of Mucopolysaccharides and Morquio Syndrome A, sponsored by CENTOGENE GmbH Rostock. Withdrawn at 5 sites in 4 countries. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2023-02-13.

Sponsored by CENTOGENE GmbH Rostock · Observational

Why this study was withdrawn
Transition to BioMetabol
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
12 Months and older
Sex
All
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Study summary

Development of a new MS-based biomarker for the early and sensitive diagnosis of Morquio disease from plasma

Read the detailed description

Morquio syndrome (mucopolysaccharidosis type IV; MPS IV) is a mucopolysaccharide storage disease that exists in two forms (Morquio syndromes A and B) and occurs because of a deficiency of the enzymes N-acetyl-galactosamine-6-sulfatase and beta-galactosidase, respectively. A deficiency of either enzyme leads to the accumulation of mucopolysaccharides in the body, abnormal skeletal development, and additional symptoms. In most cases, individuals with Morquio syndrome have normal intelligence. The clinical features of MPS IV-B are less severe than those associated with MPS IV-A. Symptoms may include growth retardation, a prominent lower face, an abnormally short neck, knees that are abnormally close together (knock knees or genu valgum), flat feet, abnormal sideways and front-to-back or side-to-side curvature of the spine (kyphoscoliosis), abnormal development of the growing ends of the long bones (epiphyses) resulting in dwarfism, and/or a prominent breast bone (pectus carinatum) as well as bell shaped chest. Though the CNS and peripheral nerves are primarily not affected the bone defects may result in neurological symptoms such as spinal cord compression. Hearing loss, weakness of the legs, and/or additional abnormalities may also occur.

The mucopolysaccharidoses (MPS) are a group of inherited lysosomal storage disorders. Lysosomes function as the primary digestive units within cells. Enzymes within lysosomes break down or digest particular nutrients, such as certain carbohydrates and fats. In individuals with MPS disorders, deficiency or malfunction of specific lysosomal enzymes lead to an abnormal accumulation of certain complex carbohydrates (mucopolysaccharides or glycosaminoglycans) in the arteries, skeleton, eyes, joints, ears, skin and/or teeth. These accumulations may also be found in the respiratory system, liver, spleen, central nervous system, blood, and bone marrow. This accumulation eventually causes progressive damage to cells, tissues, and various organ systems of the body. There are several different types and subtypes of mucopolysaccharidosis. These disorders, with one exception, are inherited as autosomal recessive traits and all vary in their clinical phenotype. Within our clinical trial we focus on MPS type IV.

New methods, like mass-spectrometry give a good chance to characterize in the blood (plasma) of affected patents specific metabolic alterations that allow to diagnose in the future the disease earlier, with a higher sensitivity and specificity. Therefore it is the goal of the study to develop new biochemical markers from the plasma of the affected patients helping to benefit the patient by an early diagnose and thereby with an earlier treatment.

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Conditions studied

  • Morquio Syndrome
  • Accumulation of Mucopolysaccharides
  • Morquio Syndrome A
  • Morquio B Disease

Keywords

  • Biomarker
  • Morquio Disease
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In context

Osteochondrodysplasias

41 studies on the registry are indexed under Osteochondrodysplasias; 11 are open to participants now.

Browse Osteochondrodysplasias studies →

Lead sponsor

CENTOGENE GmbH Rostock is the lead sponsor of 55 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Morquio disease

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 Morquio disease

Exclusion criteria

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 Morquio disease
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observation

    Patients with Morquio disease

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What researchers measure

Primary outcomes

  1. Development of a new MS-based biomarker for the early and sensitive diagnosis of Morquio 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.

    Time frame: 24 month

Secondary outcomes

  1. 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

    Time frame: 36 months

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Study locations

5 sites
  • Children's Hospital, Faculty of Medicine, Ain Shams University
    Cairo, 89075, Egypt
  • Centogene AG
    Rostock, 18055, Germany
  • Amrita Institute of Medical Sciences & Research Centre
    Cochin, Kerala 682041, India
  • Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)
    Mumbai, 400705, India
  • Lady Ridgeway Hospital for Children
    Colombo 8, 00800c, Sri Lanka
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01457456
Lead sponsor
CENTOGENE GmbH Rostock
Responsible party
Sponsor
First posted
Oct 24, 2011
Start date
Aug 20, 2018
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021
Last update
Feb 13, 2023

Study contacts

Peter Bauer, Prof.
study chair · Centogene GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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