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Intellectual DisabilityBioCDSNCT02934854

Biomarker for Creatine Deficiency Syndromes (BioCDS)

An observational study of Intellectual Disability and Developmental Delay, run by CENTOGENE GmbH Rostock at 4 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Development of a new mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample Read more about this study

Who is it for?
Ages 2 months and older
How many people
0 participants
Where
4 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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with the Creatine Deficiency Syndromes or high-grade suspicion for the Creatine Deficiency Syndromes

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 the Creatine Deficiency Syndromes or a high-grade suspicion for the Creatine Deficiency Syndromes
  • High-grade suspicion is present, if one or more inclusion criteria are valid:
  • Positive family anamnesis for the Creatine Deficiency Syndromes
  • Intellectual disability
Show all 12Show fewer
  • Seizure disorder of variable severity
  • Developmental delay
  • Speech/language delay
  • Movement disorder
  • Behavioral disorder (autism, hyperactivity, self-injury)
  • Intractable epilepsy

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 Creatine Deficiency Syndromes or no valid criteria for profound suspicion of the Creatine Deficiency Syndromes

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Egypt2 sites
  • Ain Shams University, Medical Genetics Center

    Cairo

  • Chindren's hospital, Faculty of Medicine, Ain Shams University

    Cairo

Other trials in Egypt

India1 site
  • Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)

    Mumbai, 400705

Other trials in India

Sri Lanka1 site
  • Lady Ridgeway Hospital for Children

    Colombo, 00800c

Other trials in Sri Lanka

About this study

Official title: Biomarker for Creatine Deficiency Syndromes. An International, Multicenter, Epidemiological Study.

Development of a new mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample

Read the detailed description

The Creatine Deficiency Syndromes (CDS) are a group of inborn errors of metabolism which interrupt the biosynthesis or transportation of creatine. Individuals with CDS classically present neurological symptoms (seizures, movement disorders and myopathy), and behavioral manifestations. This group includes two creatine biosynthesis disorders (Guanidinoacetate Methyltransferase Deficiency and L-Arginine: Glycine Amidinotransferase Deficiency), as well as X-linked Creatine Transporter Deficiency.

Guanidinoacetate Methyltransferase Deficiency:

Guanidinoacetate Methyltransferase Deficiency is inherited in an autosomal recessive manner and is caused by biallelic mutations in the GAMT gene. This gene maps to 19p13.3 and is involved in the biosynthesis of creatine. Individuals with this deficiency typically present with severe intellectual disabilities and seizure disorders which may be resistant to drug therapy. Behavioral problems, including autistic behaviors and self-mutilation are common, and pyramidal/extrapyramidal symptoms affect about one-half of patients. Dietary management via manipulation of critical amino acids may improve clinical outcome. Mutations in the GAMT gene are a relatively rare cause of creatine deficiency syndrome.

L-Arginine: Glycine Amidinotransferase Deficiency:

L-Arginine: Glycine Amidinotransferase Deficiency is a very rare type of CDS characterized by global developmental delay, appearing in infancy, which can be associated with language impairment and autistic behavior in some, as well as a mild to moderate intellectual disability. Progressive muscle weakness and fatigability have been reported in older patients. Seizures and failure to thrive have also been described. If creatine supplementation is administered early enough, psychomotor delay may be avoided. This deficiency is caused by mutations in GATM gene, located to chromosome 15q15.1. This gene encodes the enzyme L-Arginine: Glycine Amidinotransferase, which converts arginine and glycine to ornithine and guanidinoacetate in the creatine cycle pathway. This deficiency is transmitted in an autosomal recessive manner.

X-linked Creatine Transporter Deficiency:

X-linked Creatine Transporter Deficiency is a creatine deficiency syndrome characterized clinically by global developmental delay, intellectual disability with prominent speech/language delay, autistic behavior and seizures. Affected individuals may present low weight gain, muscular hypotonia, and poor muscle mass. Subtle dysmorphic features such as midface hypoplasia, long face, and prominent chin have been reported in various affected male patients. In adult patients, cardiac and gastrointestinal disorders have been reported. The onset of symptoms occurs during infancy, usually before the age of 2 years. Males are mainly affected, but females can also have various degrees of severity of disease manifestations. This deficiency has been reported in more than 150 individuals worldwide and is mostly due to frameshift and splicing mutations in the creatine transporter gene SLC6A8 (Xp28).

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.

Therefore it is 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.

Keywords
Creatine Transporter Deficiency (CTD), Guanidinoacetate Methyltransferase Deficiency (GAMT), Arginine: Glycine Amidinotransferase Deficiency (AGAT), Biomarker
Medical subject headings
Intellectual Disability, Learning Disabilities, Movement Disorders, Mental Disorders, Drug Resistant Epilepsy, Creatine deficiency, X-linked, Guanidinoacetate methyltransferase deficiency, Arginine-Glycine Amidinotransferase Deficiency

What participants receive

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

Study groups in NCT02934854
Study groupRoleWhat they receive
ObservationPatients with the Creatine Deficiency Syndromes or high-grade suspicion for the Creatine Deficiency Syndromes

What is being measured

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

  1. Sequencing of the Creatine Deficiency Syndromes related genes

    Next-Generation Sequencing (NGS) of the genes SLC6A8, GAMT, and GATM will be performed. The mutation will be confirmed by Sanger sequencing.

    Measured: 4 weeks

Secondary outcomes (1)
  1. The Creatine Deficiency Syndromes specific biomarker candidates finding

    The quantitative determination of small molecules (molecular weight 150-700 kD, given as ng/μl) within a dried blood spot sample will be validated via liquid chromatography multiple reaction-monitoring mass spectrometry (LC/MRM-MS) and compared with a merged control cohort. The statistically best validated molecule will be considered as a disease specific biomarker.

    Measured: 24 months

Timeline

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

  1. First posted17 Oct 2016 (estimated)
  2. Study start20 Aug 2018
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Why it stopped: Transition into 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
NCT02934854
Sponsor's protocol ID
BCDS 06-2018
Acronym
BioCDS
Status last verified
Feb 2023
First submitted
19 Sep 2016
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 Intellectual Disability and Developmental Delay, run by CENTOGENE GmbH Rostock at 4 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 12 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 4 sites in Egypt, 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?

Sequencing of the Creatine Deficiency Syndromes related genes (time frame: 4 weeks). 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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