Autism Spectrum DisorderNCT04865198
Neuralized1 and RGS14 Genes
An observational study of Autism Spectrum Disorder and High-functioning Autism, run by TC Erciyes University.
Trial summary
Autism is a broad spectrum neurodevelopmental disease. Some individuals with ADS by high cognitive functions are diagnosed with High Functioning Autism (HFA). In some studies, it has been shown that NEURL1 gene increases learning and memory and RGS14 gene is suppressed them. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, High-functioning Autism, Healthy
- What is being tested?
- Neurl1 gene expression and RGS14 gene expression
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2013to 30 Aug 2014
- 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 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Group 1: Patients diagnosed with ASD in a child psychiatry clinic. Group 2: Patients diagnosed with HFA in a child psychiatry clinic. Group 3: Healty controls
Who may be able to join
- Being diagnosed ASD or HFA patient,
- Being between the ages of 2-16.
Who cannot join
- To use medicine,
- Have a other syndromic illness,
- Being younger than 2 years old or over 16 years old.
About this study
Official title: Role of Neuralized1 and RGS14 Genes With ASD Patients
Autism is a broad spectrum neurodevelopmental disease. Some individuals with ADS by high cognitive functions are diagnosed with High Functioning Autism (HFA). In some studies, it has been shown that NEURL1 gene increases learning and memory and RGS14 gene is suppressed them. We aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD. Patients with 20 ASD and 20 HFA, and 20 healthy controls compatible with patient ages were included in this study. Expression of NEURL-1 and RGS14 genes was evaluated by quantitative Real Time PCR (qRT-PCR).
Read the detailed description
ASD is a neurological disease starting in the early stages of life and is characterized by cognitive and behavioral disorders (Ansel et al., 2008;Alvares et al., 2020). It is considered that the etiology of ASD stems from genetic, epigenetic and environmental factors; however, it has not yet been definitively clarified(Ito et al., 2017).
we aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD.
Method:
Patients with ASD (n=20) and HFA (n=20), and healthy controls (n=20) compatible with patient ages were included in this study. Clinical evaluations of the patients were made and classification was made in accordance with DSM-IV diagnostic criteria.
High Pure RNA Isolation Kit (Roche Diagnostic, Version 12, Germany) was used for RNA isolation. cDNA synthesis was performed from these RNAs with the ranscriptor High Fidelity cDNA Synthesis Kit (Roche Diagnostics, GmbH, Mannheim).
qRT-PCR was performed using the LightCycler®480 Real Time Ready Assay Master Probe Kit (Roche Diagnostics, GmbH, Mannheim).The incubation was made with the PCR device program for 10 minutes at 95oC for 45 cycles, for 10 sec at 95oC, and for 60 sec at 60oC. The Ct values were obtained from the Light Cycler 480 Software Program, and both genes were analyzed separately. The comparative CT method (2-ΔΔCT) was used to determine the relative quantification of target genes, normalized to a housekeeping gene (β-actin).
Statisticaly:
The results of the experiments were evaluated using R 3.1.1 (www.r-project.org). and Chi-Square Tests, Mann-Whitney U-Test, Kruskal-Wallis H-Tests. The P<0.05 level was taken as significant.
- Conditions
- Autism Spectrum Disorder, High-functioning Autism, Healthy
- Being tested
- Neurl1 gene expression, RGS14 gene expression
- Keywords
- ASD, High Functioning Autism, NEURL1, RGS14, Gene expression
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurl1 gene expressionDiagnostic test
This observational case control study. The gene expression was examined.
RGS14 gene expressionDiagnostic test
This observational case control study. The gene expression was examined.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Autism Spectrum Disorder (ASD) | Patients diagnosed with ASD in a child psychiatry clinic. Receives: Diagnostic Test: Neurl1 gene expression; Diagnostic Test: RGS14 gene expression | |
| Patients with High Functioning Autism (HFA) | Patients diagnosed with ASD in a child psychiatry clinic and with an IQ above 70. Receives: Diagnostic Test: Neurl1 gene expression; Diagnostic Test: RGS14 gene expression | |
| Healty control | Healthy volunteers who are in the age range compatible with the patient groups. Receives: Diagnostic Test: Neurl1 gene expression; Diagnostic Test: RGS14 gene expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEURL1 gene expression levels
After RNA isolation from blood samples of the subjects, NEURL1 gene expression was studied by QPCR method. The 2-ΔΔCT method was applied for the relative quantification of the samples that were normalized with ACTB.
Measured: Two months
RGS14 gene expression levels
After RNA isolation from blood samples of the subjects, RGS14 gene expression was studied by QPCR method. The 2-ΔΔCT method was applied for the relative quantification of the samples that were normalized with ACTB.
Measured: Two months
Secondary outcomes (6)
Age
Age of subjects
Measured: an average of 1 year
Gender
Gender (male/female) of subjects
Measured: an average of 1 year
Intellectual disability (ID)
Intellectual disability is when a person has certain limitations in cognitive functioning and skills, including communication, social and self-care skills.It was determined according to DSM-IV diagnostic criteria and clinical evaluation.
Measured: an average of 1 year
Consanguinity
Relationships of consanguinity between subjects were evaluated in terms of pathogenesis of the disease.
Measured: an average of 1 year
Presence of Neurological Disease in Relatives
In the presence of a neurological disease in relatives, its relationship with the pathogenesis of the disease was evaluated.
Measured: an average of 1 year
Corelation tests
The relationships of the clinical and demographical findings in the study groups with the genes were evaluated statistically.
Measured: an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start10 Jan 2013
- Primary completion30 Aug 2014
- Study completion30 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ozkul, TC Erciyes University
- Investigators
- Hamiyet Eciroğlu, Phd. St., Principal investigator, Alanya Alaaddin Keykubat UniversityElif F. Şener, Assoc. Prof., Principal investigator, TC Erciyes UniversityDidem B. Öztop, Assoc. Prof., Principal investigator, Ankara UniversitySevgi Özmen, Assoc. Prof., Principal investigator, TC Erciyes UniversityDilek Kaan, Phd., Principal investigator, TC Erciyes UniversityYusuf Özkul, Prof. Dr., Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865198
- Sponsor's protocol ID
- NEURL1RGS14
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The details and reports of the study will be shared after the article is published.
Publications
Ansel A, Rosenzweig JP, Zisman PD, Melamed M, Gesundheit B. Variation in Gene Expression in Autism Spectrum Disorders: An Extensive Review of Transcriptomic Studies. Front Neurosci. 2017 Jan 5;10:601. doi: 10.3389/fnins.2016.00601. eCollection 2016.
PubMed 28105001Charman T, Baird G. Practitioner review: Diagnosis of autism spectrum disorder in 2- and 3-year-old children. J Child Psychol Psychiatry. 2002 Mar;43(3):289-305. doi: 10.1111/1469-7610.00022.
PubMed 11944873Ito H, Morishita R, Nagata KI. Autism spectrum disorder-associated genes and the development of dentate granule cells. Med Mol Morphol. 2017 Sep;50(3):123-129. doi: 10.1007/s00795-017-0161-z. Epub 2017 May 22.
PubMed 28534217Rao PA, Beidel DC, Murray MJ. Social skills interventions for children with Asperger's syndrome or high-functioning autism: a review and recommendations. J Autism Dev Disord. 2008 Feb;38(2):353-61. doi: 10.1007/s10803-007-0402-4. Epub 2007 Jul 20.
PubMed 17641962Sener EF, Cikili Uytun M, Korkmaz Bayramov K, Zararsiz G, Oztop DB, Canatan H, Ozkul Y. The roles of CC2D1A and HTR1A gene expressions in autism spectrum disorders. Metab Brain Dis. 2016 Jun;31(3):613-9. doi: 10.1007/s11011-016-9795-0. Epub 2016 Jan 19.
PubMed 26782176Misra V. The social brain network and autism. Ann Neurosci. 2014 Apr;21(2):69-73. doi: 10.5214/ans.0972.7531.210208.
PubMed 25206065Sullivan JM, De Rubeis S, Schaefer A. Convergence of spectrums: neuronal gene network states in autism spectrum disorder. Curr Opin Neurobiol. 2019 Dec;59:102-111. doi: 10.1016/j.conb.2019.04.011. Epub 2019 Jun 18.
PubMed 31220745O'Brien G, Pearson J. Autism and learning disability. Autism. 2004 Jun;8(2):125-40. doi: 10.1177/1362361304042718.
PubMed 15165430Landsiedel J, Williams DM, Abbot-Smith K. A Meta-Analysis and Critical Review of Prospective Memory in Autism Spectrum Disorder. J Autism Dev Disord. 2017 Mar;47(3):646-666. doi: 10.1007/s10803-016-2987-y.
PubMed 28116668Vellano CP, Lee SE, Dudek SM, Hepler JR. RGS14 at the interface of hippocampal signaling and synaptic plasticity. Trends Pharmacol Sci. 2011 Nov;32(11):666-74. doi: 10.1016/j.tips.2011.07.005. Epub 2011 Sep 8.
PubMed 21906825Lamsa K, Lau P. Long-term plasticity of hippocampal interneurons during in vivo memory processes. Curr Opin Neurobiol. 2019 Feb;54:20-27. doi: 10.1016/j.conb.2018.08.006. Epub 2018 Sep 5.
PubMed 30195105Zeithamova D, Schlichting ML, Preston AR. The hippocampus and inferential reasoning: building memories to navigate future decisions. Front Hum Neurosci. 2012 Mar 26;6:70. doi: 10.3389/fnhum.2012.00070. eCollection 2012.
PubMed 22470333Besag FM. Epilepsy in patients with autism: links, risks and treatment challenges. Neuropsychiatr Dis Treat. 2017 Dec 18;14:1-10. doi: 10.2147/NDT.S120509. eCollection 2018.
PubMed 29296085Richter JD. Cytoplasmic polyadenylation in development and beyond. Microbiol Mol Biol Rev. 1999 Jun;63(2):446-56. doi: 10.1128/MMBR.63.2.446-456.1999.
PubMed 10357857Jacobs D, Steyaert J, Dierickx K, Hens K. Physician View and Experience of the Diagnosis of Autism Spectrum Disorder in Young Children. Front Psychiatry. 2019 May 28;10:372. doi: 10.3389/fpsyt.2019.00372. eCollection 2019.
PubMed 31191373
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neuralized1 and RGS14 Genes With ASD Patients
- ClinicalTrials.gov ID
- NCT04865198
- Acronym / sponsor ID
- NEURL1RGS14
- Conditions
- Autism Spectrum Disorder, High-functioning Autism, Healthy
- Keywords
- ASD, High Functioning Autism, NEURL1, RGS14, Gene expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 30 Aug 2014 (actual)
- Study completion
- 30 Aug 2014 (actual)
- First posted
- 29 Apr 2021 (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.
Autism is a broad spectrum neurodevelopmental disease. Some individuals with ADS by high cognitive functions are diagnosed with High Functioning Autism (HFA). In some studies, it has been shown that NEURL1 gene increases learning and memory and RGS14 gene is suppressed them. We aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD. Patients with 20 ASD and 20 HFA, and 20 healthy controls compatible with patient ages were included in this study. Expression of NEURL-1 and RGS14 genes was evaluated by quantitative Real Time PCR (qRT-PCR).
Detailed description
ASD is a neurological disease starting in the early stages of life and is characterized by cognitive and behavioral disorders (Ansel et al., 2008;Alvares et al., 2020). It is considered that the etiology of ASD stems from genetic, epigenetic and environmental factors; however, it has not yet been definitively clarified(Ito et al., 2017).
we aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD.
Method:
Patients with ASD (n=20) and HFA (n=20), and healthy controls (n=20) compatible with patient ages were included in this study. Clinical evaluations of the patients were made and classification was made in accordance with DSM-IV diagnostic criteria.
High Pure RNA Isolation Kit (Roche Diagnostic, Version 12, Germany) was used for RNA isolation. cDNA synthesis was performed from these RNAs with the ranscriptor High Fidelity cDNA Synthesis Kit (Roche Diagnostics, GmbH, Mannheim).
qRT-PCR was performed using the LightCycler®480 Real Time Ready Assay Master Probe Kit (Roche Diagnostics, GmbH, Mannheim).The incubation was made with the PCR device program for 10 minutes at 95oC for 45 cycles, for 10 sec at 95oC, and for 60 sec at 60oC. The Ct values were obtained from the Light Cycler 480 Software Program, and both genes were analyzed separately. The comparative CT method (2-ΔΔCT) was used to determine the relative quantification of target genes, normalized to a housekeeping gene (β-actin).
Statisticaly:
The results of the experiments were evaluated using R 3.1.1 (www.r-project.org). and Chi-Square Tests, Mann-Whitney U-Test, Kruskal-Wallis H-Tests. The P<0.05 level was taken as significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Autism Spectrum Disorder (ASD) | – | Diagnostic Test: Neurl1 gene expression, Diagnostic Test: RGS14 gene expressionPatients diagnosed with ASD in a child psychiatry clinic. |
| Patients with High Functioning Autism (HFA) | – | Diagnostic Test: Neurl1 gene expression, Diagnostic Test: RGS14 gene expressionPatients diagnosed with ASD in a child psychiatry clinic and with an IQ above 70. |
| Healty control | – | Diagnostic Test: Neurl1 gene expression, Diagnostic Test: RGS14 gene expressionHealthy volunteers who are in the age range compatible with the patient groups. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Group 1: Patients diagnosed with ASD in a child psychiatry clinic. Group 2: Patients diagnosed with HFA in a child psychiatry clinic. Group 3: Healty controls
Key inclusion criteria (2 listed)
- Being diagnosed ASD or HFA patient,
- Being between the ages of 2-16.
Key exclusion criteria (3 listed)
- To use medicine,
- Have a other syndromic illness,
- Being younger than 2 years old or over 16 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurl1 gene expressionThis observational case control study. The gene expression was examined. | Diagnostic test | Healty control, Patients with Autism Spectrum Disorder (ASD), Patients with High Functioning Autism (HFA) |
| RGS14 gene expressionThis observational case control study. The gene expression was examined. | Diagnostic test | Healty control, Patients with Autism Spectrum Disorder (ASD), Patients with High Functioning Autism (HFA) |
Primary outcome
NEURL1 gene expression levels
Time frame: Two months
After RNA isolation from blood samples of the subjects, NEURL1 gene expression was studied by QPCR method. The 2-ΔΔCT method was applied for the relative quantification of the samples that were normalized with ACTB.
RGS14 gene expression levels
Time frame: Two months
After RNA isolation from blood samples of the subjects, RGS14 gene expression was studied by QPCR method. The 2-ΔΔCT method was applied for the relative quantification of the samples that were normalized with ACTB.
6 secondary outcomes
Age
Time frame: an average of 1 year
Gender
Time frame: an average of 1 year
Intellectual disability (ID)
Time frame: an average of 1 year
Consanguinity
Time frame: an average of 1 year
Presence of Neurological Disease in Relatives
Time frame: an average of 1 year
Corelation tests
Time frame: an average of 1 year"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 28105001Ansel A, Rosenzweig JP, Zisman PD, Melamed M, Gesundheit B. Variation in Gene Expression in Autism Spectrum Disorders: An Extensive Review of Transcriptomic Studies. Front Neurosci. 2017 Jan 5;10:601. doi: 10.3389/fnins.2016.00601. eCollection 2016.
- Background: PubMed 11944873Charman T, Baird G. Practitioner review: Diagnosis of autism spectrum disorder in 2- and 3-year-old children. J Child Psychol Psychiatry. 2002 Mar;43(3):289-305. doi: 10.1111/1469-7610.00022.
- Background: PubMed 28534217Ito H, Morishita R, Nagata KI. Autism spectrum disorder-associated genes and the development of dentate granule cells. Med Mol Morphol. 2017 Sep;50(3):123-129. doi: 10.1007/s00795-017-0161-z. Epub 2017 May 22.
- Background: PubMed 17641962Rao PA, Beidel DC, Murray MJ. Social skills interventions for children with Asperger's syndrome or high-functioning autism: a review and recommendations. J Autism Dev Disord. 2008 Feb;38(2):353-61. doi: 10.1007/s10803-007-0402-4. Epub 2007 Jul 20.
- Background: PubMed 26782176Sener EF, Cikili Uytun M, Korkmaz Bayramov K, Zararsiz G, Oztop DB, Canatan H, Ozkul Y. The roles of CC2D1A and HTR1A gene expressions in autism spectrum disorders. Metab Brain Dis. 2016 Jun;31(3):613-9. doi: 10.1007/s11011-016-9795-0. Epub 2016 Jan 19.
- Background: PubMed 25206065Misra V. The social brain network and autism. Ann Neurosci. 2014 Apr;21(2):69-73. doi: 10.5214/ans.0972.7531.210208.
- Background: PubMed 31220745Sullivan JM, De Rubeis S, Schaefer A. Convergence of spectrums: neuronal gene network states in autism spectrum disorder. Curr Opin Neurobiol. 2019 Dec;59:102-111. doi: 10.1016/j.conb.2019.04.011. Epub 2019 Jun 18.
- Background: PubMed 15165430O'Brien G, Pearson J. Autism and learning disability. Autism. 2004 Jun;8(2):125-40. doi: 10.1177/1362361304042718.
- Background: PubMed 28116668Landsiedel J, Williams DM, Abbot-Smith K. A Meta-Analysis and Critical Review of Prospective Memory in Autism Spectrum Disorder. J Autism Dev Disord. 2017 Mar;47(3):646-666. doi: 10.1007/s10803-016-2987-y.
- Background: PubMed 21906825Vellano CP, Lee SE, Dudek SM, Hepler JR. RGS14 at the interface of hippocampal signaling and synaptic plasticity. Trends Pharmacol Sci. 2011 Nov;32(11):666-74. doi: 10.1016/j.tips.2011.07.005. Epub 2011 Sep 8.
- Background: PubMed 30195105Lamsa K, Lau P. Long-term plasticity of hippocampal interneurons during in vivo memory processes. Curr Opin Neurobiol. 2019 Feb;54:20-27. doi: 10.1016/j.conb.2018.08.006. Epub 2018 Sep 5.
- Background: PubMed 22470333Zeithamova D, Schlichting ML, Preston AR. The hippocampus and inferential reasoning: building memories to navigate future decisions. Front Hum Neurosci. 2012 Mar 26;6:70. doi: 10.3389/fnhum.2012.00070. eCollection 2012.
- American Psychiatric Association. Diagnostic and statistical manual of mental disordersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The details and reports of the study will be shared after the article is published.
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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.
Hamiyet Eciroğlu, Phd. St. principal investigator
Alanya Alaaddin Keykubat University
Elif F. Şener, Assoc. Prof. principal investigator
TC Erciyes University
Didem B. Öztop, Assoc. Prof. principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and High-functioning Autism, run by TC Erciyes University.
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 2 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: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NEURL1 gene expression levels (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865198, which also lists 24 linked publications.
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 26 Jul 2022.