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Mental RetardationBioSanfilippoNCT02298686

Biomarker for Sanfilippo Type A-B-C-D Disease (BioSanfilippo)

An observational study of Mental Retardation and Developmental Delay, run by CENTOGENE GmbH Rostock at 5 sites in 4 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of Sanfilippo Disease Type A-B-C-D from blood (plasma) Read more about this study

Who is it for?
Ages 2 months and older
Conditions the study is for
Mental Retardation, Developmental Delay
How many people
0 participants
Where
5 sitesin 4 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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with Sanfilippo Type A-B-C-D disease or high-grade suspicion for Sanfilippo Type A-B-C-D 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 month
  • The patient has a diagnosis of Sanfilippo Type A-B-C-D disease or a high-grade suspicion for Sanfilippo Type A-B-C-D disease
  • High-grade suspicion present, if one or more inclusion criteria are valid:
  • Positive family anamnesis for Sanfilippo Type A-B-C-D disease
  • Dysostosis multiplex without identifiable cause
Show all 10Show fewer
  • Splenomegaly without identifiable cause
  • Hepatomegaly without identifiable cause
  • Heparan sulfate excretion in urine
  • CNS involvement without identifiable cause

Who cannot join

  • No Informed consent from the patient or the parents before any study related procedures.
  • Patients of both gender younger than 2 month
  • No diagnosis of Sanfilippo Type A-B-C-D disease or no valid criteria for profound suspicion of Sanfilippo Type A-B-C-D disease

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

India2 sites
  • Amrita Institute of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)

    Mumbai, 400705

Other trials in India

Egypt1 site
  • Children's Hospital, Faculty of Medicine, Ain Shams University

    Cairo, 89075

Other trials in Egypt

Germany1 site
  • Centogene AG

    Rostock, 18055

Other trials in Germany

Sri Lanka1 site
  • Lady Ridgeway Hospital for Children

    Colombo, 00800c

Other trials in Sri Lanka

About this study

Official title: Biomarker for Sanfilippo Disease Type A-B-C-D AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL

Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of Sanfilippo Disease Type A-B-C-D from blood (plasma)

Read the detailed description

The Mucopolysaccharidoses (MPS Disorders) are a group of rare genetic disorders caused by the deficiency of one of the lysosomal enzymes, resulting in an inability to metabolize complex carbohydrates (mucopolysaccharides) into simpler molecules. High concentrations of mucopolysaccharides in the cells of the central nervous system, including the brain, cause the neu-rological and developmental deficits that accompany these disorders.

Lysosomal enzymes are found in the lysosome, a very small membrane-contained body (organelle) found in the cytoplasm of most cells. The lysosome is often called the "waste disposal plant" of the cell. The accumulation of these large, undegraded mucopolysaccharides in the cells of the body is the cause of a number of physical symptoms and abnormalities.

MPS-III (Sanfilippo Syndrome) is one of seven MPS Disorders. It is an inborn error of metabolism that is transmitted as an autosomal recessive genetic disorder. MPS-lll has been categorized into four subtypes: MPS-III Type A, MPS-III Type B, MPS-III Type C, and MPS-III Type D depending on the gene defect (MPS3A - SGSH gene, MPS3B - NAGLU gene, MPS3C - HGSNAT, MPS3D - GNS gene). All types are associated with some degree of mental deterioration, but the severity depends on the particular type of MPS-lll. Several physical defects may be present, and the severity of these defects varies with the type of MPS-III. In the case of each type of MPS-III, abnormal amounts of a specific, chemically complex molecule is excreted in the urine. The excreted chemical is the same for each of the four types of MPS-III, since the defective gene involves a different step, and thus a different enzyme, in the deconstruction of the same mucopolysaccharide. By testing for one or another of these enzymes, the variant type may be readily identified.

Symptoms Patients with Sanfilippo Syndrome (MPS Type III) usually appear normal at birth, but mental retardation and developmental delay is usually evident by age 3-5 years. Mental and motor development reaches a peak by 3-6 years of age after which behavioral disturbances and intellectual decline usually occur. However, hyperactivity and irritability may become obvious earlier.

The following symptoms are usually apparent by approximately age 10: neurological deficits and signs, wobbly and erratic gait and difficulty walking (ataxia), hyperactivity (hyperkinetic syndrome), mental retardation, stiff joints, hernias, enlarged liver and/or spleen (hepatosplenomegaly).Growth is usually minimally affected; the head may be enlarged, and abnormal hairiness (hirsutism) may occur. Mild coarsening of facial features also characterizes this disorder. In some cases deafness may also occur.

Causes All four varieties of MPS-III are autosomal recessive genetic disorders.

The gene abnormalities associated with MSS-IIIA, MPS-IIIB, MPS-IIIC and MPS-IIID have been identified. The Gene Map Loci are as follows:

MPS-IIIA --------- 17q25.3; SGSH gene

MPS-IIIB --------- 17q21.2; NAGLU gene

MPS-IIIC --------- 8p11.21; HGSNAT gene

MPS-IIID --------- 12q14.3; GNS gene

Genetic diseases are determined by the combination of genes for a particular trait that are on the chromosomes received from the father and the mother.

Recessive genetic disorders occur when an individual inherits the same abnormal gene for the same trait from each parent. If an individual receives one normal gene and one gene for the disease, the person will be a carrier for the disease, but usually will not show symptoms. The risk for two carrier parents to both pass the defective gene and, therefore, have an affected child is 25% with each pregnancy. The risk to have a child who is a carrier like the parents is 50% with each pregnancy. The chance for a child to receive normal genes from both parents and be genetically normal for that particular trait is 25%. The risk is the same for males and females.

All individuals carry 4-5 abnormal genes. Parents who are close relatives (consanguineous) have a higher chance than unrelated parents to both carry the same abnormal gene, which increases the risk to have children with a recessive genetic disorder.

Keywords
Sanfilippo Disease Type A-B-C-D, Biomarker
Medical subject headings
Intellectual Disability, Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02298686
Study groupRoleWhat they receive
ObservationPatients with Sanfilippo Type A-B-C-D disease or high-grade suspicion for Sanfilippo Type A-B-C-D disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of a new MS-based biomarker for the early and sensitive diagnosis of Sanfilippo Type A-B-C-D disease from 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)
  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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2014 (estimated)
  2. Study start20 Aug 2018
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Why it stopped: Transition to BioMetabol

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298686
Sponsor's protocol ID
BSF01-2014
Acronym
BioSanfilippo
Status last verified
Feb 2023
First submitted
23 Oct 2014
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Retardation and Developmental Delay, run by CENTOGENE GmbH Rostock at 5 sites in 4 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 5 sites in India, Egypt, Germany, 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 diagnosis of Sanfilippo Type A-B-C-D disease from 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.

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