Alpha-Mannosidase B DeficiencyBioMannosidoNCT03264040
Biomarker for Mannosidosis Disease (BioMannosidosis)
An observational study of Alpha-Mannosidase B Deficiency and Lysosomal Alpha B Mannosidosis, run by CENTOGENE GmbH Rostock at 3 sites in 3 countries.
Trial summary
Development of a new MS-based biomarker for the early and sensitive diagnosis of Mannosidosis disease from blood (plasma) Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Alpha-Mannosidase B Deficiency, Lysosomal Alpha B Mannosidosis, Alpha-Mannosidase Deficiency
- How many people
- 0 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Aug 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with Mannosidosis disease or high-grade suspicion for Mannosidosis disease
Who may be able to join
- Informed consent will be obtained from the patient or the parents before any study related procedures.
- Patients of both genders older than 2 months
- The patient has a diagnosis of Alpha-Mannosidosis disease or a high grade suspicion for Alpha-Mannosidosis disease
- High grade suspicion present, if one or more inclusion criteria are valid:
- Positive family anamnesis for Alpha-Mannosidosis disease
- rounded eyebrows
Show all 10Show fewer
- large head
- large ears
- flattened bridge of the nose
- deformations of the bones in the spine (vertebrae)
Who cannot join
- No Informed consent from the patient or the parents before any study related procedures.
- Patients of both gender younger than 2 months
- No diagnosis of Alpha-Mannosidosis disease or no valid criteria for profound suspicion of Alpha-Mannosidosis disease
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
India1 site
Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)
Mumbai, 400705
About this study
Official title: Biomarker for Mannosidosis Disease - An International, Multicenter, Epidemiological Protocol
Development of a new MS-based biomarker for the early and sensitive diagnosis of Mannosidosis disease from blood (plasma)
Read the detailed description
Alpha-Mannosidosis is a rare lysosomal storage disorder of the Glycoprotein family of diseases and is closely related to Mucopolysaccharidoses.
Alpha-Mannosidosis was first described by Dr Oekerman, from Lund in Sweden in 1967. There is another variant known as Beta-Mannosidosis, which is extremely rare and has produced a wide range of clinical abnormalities in the few patients described with this disorder.
A Alpha-Mannosidosis is a rare inherited disorder that causes problems in many organs and tissues of the body. Affected individuals may have intellectual disability, distinctive facial features, and skeletal abnormalities. Characteristic facial features can include a large head, prominent forehead, low hairline, rounded eyebrows, large ears, flattened bridge of the nose, protruding jaw, widely spaced teeth, overgrown gums, and large tongue. The skeletal abnormalities that can occur in this disorder include reduced bone density (osteopenia), thickening of the bones at the top of the skull (calvaria), deformations of the bones in the spine (vertebrae), bowed legs or knock knees, and deterioration of the bones and joints.
Affected individuals may also experience difficulty in coordinating movements (ataxia); muscle weakness (myopathy); delay in developing motor skills such as sitting and walking; speech impairments; increased risk of infections; enlargement of the liver and spleen (hepatosplenomegaly); a buildup of fluid in the brain (hydrocepha-lus); hearing loss; and a clouding of the lens of the eye (cataract). Some people with Alpha-Mannosidosis experience psychiatric symptoms such as depression, anxiety, or hallucinations; episodes of psychiatric disturbance may be triggered by stressors such as having undergone surgery, emotional upset, or changes in routine.
The signs and symptoms of Alpha-Mannosidosis can range from mild to severe. The disorder may appear in infancy with rapid progression and severe neurological deterioration. Individuals with this early-onset form of Alpha-Mannosidosis often do not survive past childhood. In the most severe cases, an affected fetus may die before birth. Other individuals with Alpha-Mannosidosis experience milder signs and symptoms that appear later and progress more slowly. People with later-onset alpha-mannosidosis may survive into their fifties. The mildest cases may be detected only through laboratory testing and result in few if any symptoms.
Alpha-mannosidosis is estimated to occur in approximately 1 in 500,000 people worldwide.
Mutations in the MAN2B1 gene cause Alpha-Mannosidosis. This gene provides instructions for making the enzyme alpha-mannosidase. This enzyme works in the lysosomes, which are compartments that digest and recycle materials in the cell. With-in lysosomes, the enzyme helps break down complexes of sugar molecules (oligo-saccharides) attached to certain proteins (glycoproteins). In particular, alpha-mannosidase helps break down oligosaccharides containing a sugar molecule called mannose.
Mutations in the MAN2B1 gene interfere with the ability of the alpha-mannosidase enzyme to perform its role in breaking down mannose-containing oligosaccharides. These oligosaccharides accumulate in the lysosomes and cause cells to malfunction and eventually die. Tissues and organs are damaged by the abnormal accumulation of oligosaccharides and the resulting cell death, leading to the characteristic features of Alpha-Mannosidosis.
New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood (plasma) of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity.
Therefore it is the goal of the study to identify and validate a new biochemical marker from the plasma of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.
- Conditions
- Alpha-Mannosidase B Deficiency, Lysosomal Alpha B Mannosidosis, Alpha-Mannosidase Deficiency
- Keywords
- Mannosidosis, Biomarker
- Medical subject headings
- alpha-Mannosidosis, Mannosidase Deficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients with Mannosidosis disease or high-grade suspicion for Mannosidosis disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a new MS-based biomarker for the early and sensitive diagno-sis of Mannosidosis 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.
Measured: 24 months
Secondary outcomes (1)
Testing for clinical robustness, specificity and long-term stability of the bi-omarker
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start20 Aug 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Transition to BioMetabol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-Mannosidase B DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bauer, Prof., Study chair, Centogene GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264040
- Sponsor's protocol ID
- BMA 06-2018
- Acronym
- BioMannosido
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2017
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Mannosidosis Disease - An International, Multicenter, Epidemiological Protocol
- ClinicalTrials.gov ID
- NCT03264040
- Acronym / sponsor ID
- BioMannosido / BMA 06-2018
- Conditions
- Alpha-Mannosidase B Deficiency, Lysosomal Alpha B Mannosidosis, Alpha-Mannosidase Deficiency
- Keywords
- Mannosidosis, Biomarker
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Transition to BioMetabol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of a new MS-based biomarker for the early and sensitive diagnosis of Mannosidosis disease from blood (plasma)
Detailed description
Alpha-Mannosidosis is a rare lysosomal storage disorder of the Glycoprotein family of diseases and is closely related to Mucopolysaccharidoses.
Alpha-Mannosidosis was first described by Dr Oekerman, from Lund in Sweden in 1967. There is another variant known as Beta-Mannosidosis, which is extremely rare and has produced a wide range of clinical abnormalities in the few patients described with this disorder.
A Alpha-Mannosidosis is a rare inherited disorder that causes problems in many organs and tissues of the body. Affected individuals may have intellectual disability, distinctive facial features, and skeletal abnormalities. Characteristic facial features can include a large head, prominent forehead, low hairline, rounded eyebrows, large ears, flattened bridge of the nose, protruding jaw, widely spaced teeth, overgrown gums, and large tongue. The skeletal abnormalities that can occur in this disorder include reduced bone density (osteopenia), thickening of the bones at the top of the skull (calvaria), deformations of the bones in the spine (vertebrae), bowed legs or knock knees, and deterioration of the bones and joints.
Affected individuals may also experience difficulty in coordinating movements (ataxia); muscle weakness (myopathy); delay in developing motor skills such as sitting and walking; speech impairments; increased risk of infections; enlargement of the liver and spleen (hepatosplenomegaly); a buildup of fluid in the brain (hydrocepha-lus); hearing loss; and a clouding of the lens of the eye (cataract). Some people with Alpha-Mannosidosis experience psychiatric symptoms such as depression, anxiety, or hallucinations; episodes of psychiatric disturbance may be triggered by stressors such as having undergone surgery, emotional upset, or changes in routine.
The signs and symptoms of Alpha-Mannosidosis can range from mild to severe. The disorder may appear in infancy with rapid progression and severe neurological deterioration. Individuals with this early-onset form of Alpha-Mannosidosis often do not survive past childhood. In the most severe cases, an affected fetus may die before birth. Other individuals with Alpha-Mannosidosis experience milder signs and symptoms that appear later and progress more slowly. People with later-onset alpha-mannosidosis may survive into their fifties. The mildest cases may be detected only through laboratory testing and result in few if any symptoms.
Alpha-mannosidosis is estimated to occur in approximately 1 in 500,000 people worldwide.
Mutations in the MAN2B1 gene cause Alpha-Mannosidosis. This gene provides instructions for making the enzyme alpha-mannosidase. This enzyme works in the lysosomes, which are compartments that digest and recycle materials in the cell. With-in lysosomes, the enzyme helps break down complexes of sugar molecules (oligo-saccharides) attached to certain proteins (glycoproteins). In particular, alpha-mannosidase helps break down oligosaccharides containing a sugar molecule called mannose.
Mutations in the MAN2B1 gene interfere with the ability of the alpha-mannosidase enzyme to perform its role in breaking down mannose-containing oligosaccharides. These oligosaccharides accumulate in the lysosomes and cause cells to malfunction and eventually die. Tissues and organs are damaged by the abnormal accumulation of oligosaccharides and the resulting cell death, leading to the characteristic features of Alpha-Mannosidosis.
New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood (plasma) of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity.
Therefore it is the goal of the study to identify and validate a new biochemical marker from the plasma of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with Mannosidosis disease or high-grade suspicion for Mannosidosis disease |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Mannosidosis disease or high-grade suspicion for Mannosidosis disease
Key inclusion criteria (10 listed)
- Informed consent will be obtained from the patient or the parents before any study related procedures.
- Patients of both genders older than 2 months
- The patient has a diagnosis of Alpha-Mannosidosis disease or a high grade suspicion for Alpha-Mannosidosis disease
- High grade suspicion present, if one or more inclusion criteria are valid:
Key exclusion criteria (3 listed)
- No Informed consent from the patient or the parents before any study related procedures.
- Patients of both gender younger than 2 months
- No diagnosis of Alpha-Mannosidosis disease or no valid criteria for profound suspicion of Alpha-Mannosidosis disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a new MS-based biomarker for the early and sensitive diagno-sis of Mannosidosis disease from blood (plasma)
Time frame: 24 months
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.
1 secondary outcome
Testing for clinical robustness, specificity and long-term stability of the bi-omarker
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Centogene is one of the leading laboratories focusing on genetic testing for rare hereditary disorders. We now offer more than 2200 routine genetic and biochemical tests.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bauer, Prof. study chair
Centogene GmbH
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha-Mannosidase B Deficiency and Lysosomal Alpha B Mannosidosis, run by CENTOGENE GmbH Rostock at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, India, Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a new MS-based biomarker for the early and sensitive diagno-sis of Mannosidosis disease from blood (plasma) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.