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.
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
- Conditions the study is for
- Intellectual Disability, Developmental Delay, Movement Disorder
- 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
India1 site
Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)
Mumbai, 400705
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.
- Conditions
- Intellectual Disability, Developmental Delay, Movement Disorder, Behavioral Disorder, Intractable Epilepsy
- 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 group | Role | What they receive |
|---|---|---|
| Observation | Patients 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.
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)
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.
- First posted17 Oct 2016 (estimated)
- Study start20 Aug 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Transition into BioMetabol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- 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
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 Creatine Deficiency Syndromes. An International, Multicenter, Epidemiological Study.
- ClinicalTrials.gov ID
- NCT02934854
- Acronym / sponsor ID
- BioCDS / BCDS 06-2018
- Conditions
- Intellectual Disability, Developmental Delay, Movement Disorder, Behavioral Disorder, Intractable Epilepsy
- Keywords
- Creatine Transporter Deficiency (CTD), Guanidinoacetate Methyltransferase Deficiency (GAMT), Arginine: Glycine Amidinotransferase Deficiency (AGAT), Biomarker
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Transition into 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
- 17 Oct 2016 (estimated)
- 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 mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with the Creatine Deficiency Syndromes or high-grade suspicion for the Creatine Deficiency Syndromes |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the Creatine Deficiency Syndromes or high-grade suspicion for the Creatine Deficiency Syndromes
Key inclusion criteria (12 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 the Creatine Deficiency Syndromes or a high-grade suspicion for the Creatine Deficiency Syndromes
- Positive family anamnesis for the Creatine Deficiency Syndromes
- Intellectual disability
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 Creatine Deficiency Syndromes or no valid criteria for profound suspicion of the Creatine Deficiency Syndromes
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
Sequencing of the Creatine Deficiency Syndromes related genes
Time frame: 4 weeks
Next-Generation Sequencing (NGS) of the genes SLC6A8, GAMT, and GATM will be performed. The mutation will be confirmed by Sanger sequencing.
1 secondary outcome
The Creatine Deficiency Syndromes specific biomarker candidates finding
Time frame: 24 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.
- Individual participant dataSharing planned: Undecided
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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
4 sites in 3 countries: see every site and its status.
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.