Investigation of the Genetic and Environmental Causes of Autism: a Multi-Center Study

NCT06662591 | Not Yet Recruiting DMC

• 2 other identifiers: ERC2025SYG-TR-ASD-MultiOmicsHRU.24/16/37
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 20

Brief Summary

The goal of this observational study is to investigate the genetic and epigenetic mechanisms that may contribute to the development of Autism Spectrum Disorder (ASD) in individuals of different age groups. The study aims to explore how genetic variants and environmental factors interact to influence the risk of ASD. The main questions it aims to answer are:

• Which genetic variants are most strongly associated with the development of ASD?
• How do environmental factors, such as prenatal exposure, influence these genetic risks?
• Can the combination of genetic and epigenetic data improve early detection or intervention strategies for ASD? Participants will:
• Provide biological samples for genetic and epigenetic analysis.
• Complete detailed questionnaires regarding environmental exposures and family history.
• Participate in clinical assessments to evaluate the severity of ASD symptoms. Researchers will compare genetic and environmental data between individuals with ASD and those without the disorder to understand how these factors may contribute to the risk of ASD. This multi-center study will take place across several universities and hospitals in Türkiye, focusing on the potential interplay between inherited genetic factors and environmental influences.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Autism Spectrum Disorder; Genetic Variants; Epigenetics; Transcriptomics; DNA Methylation; Gene Expression Regulation; Polygenic Risk Score; Biomarkers; Whole Genome Sequencing; Epitranscriptomics; Expression Quantitative Trait Loci; Methylation Quantitative Trait Loci; Differentially Methylated Regions; Epigenome-Wide Association Study; Genome-Wide Association Study; RNA Sequencing; Allele-Specific Methylation; Single Nucleotide Polymorphisms; Copy Number Variations; Insertions and Deletions

Outcome Measures

Primary Outcomes (1)

• Finalization of Clinical Data Recruitment

  The primary outcome will be the recruitment of individuals diagnosed with Autism Spectrum Disorder (ASD) and unaffected controls. Comprehensive clinical, sociodemographic, and phenotypic data will be collected, including diagnostic assessments using standardized tools (e.g., ADOS, SCQ).

  Expected to complete within 24 months of study initiation.

Secondary Outcomes (2)

• Collection and Completion of Genetic Raw Data (WGS and WGBS)

  Expected to complete within 30 months of study initiation

• Integration of Genetic Data

  Expected to complete within 60 months of study initiation.

Other Outcomes (1)

• Complete (Final) Outcome Measure : Association Between Clinical and Genetic Data

  Expected within 66 months, after all data collection and analysis stages have been completed.

Study Arms (3)

ASD Case Group

Represents individuals diagnosed with Autism Spectrum Disorder (ASD), who will undergo genetic, epigenetic, and transcriptomic analysis.

Control Group

Represents unaffected individuals, serving as the comparison group for genetic and molecular analyses.

HOT Cluster Biomarker Group

Represents participants selected after secondary outcome results based on HOT cluster analysis, who will undergo ELISA to study potential biomarkers derived from RNA transcriptome pathway analysis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals diagnosed with Autism Spectrum Disorder (ASD) or exhibiting autism-like traits, selected from clinical centers specializing in neurodevelopmental disorders. The population will also include a healthy control group, matched by age, gender, and socio-demographic variables, recruited from the general community. The ASD cohort will include participants across a range of functional levels, from high-functioning to low-functioning autism, as well as those with developmental profiles and comorbid conditions. Controls will be free of psychiatric or neurological diagnoses and chronic conditions.

You may qualify if:

• Healthy Control Group: Age-, gender-, and socio-demographically matched individuals without any psychiatric or neurological disorder.
• ASD Individuals of Varying Functional Levels: Participants with ASD from a broad range of functional abilities, from high-functioning to low-functioning autism.
• Informed Consent: Written informed consent from participants over 18 years of age. For participants under 18, consent from parents or legal guardians.

You may not qualify if:

• Known Genetic Syndromes or Chromosomal Anomalies: Individuals with genetic conditions such as Down syndrome or Fragile X syndrome.
• History of Genetic or Experimental Therapies: Participants with previous gene or cell therapy, frequent blood transfusions, or bone marrow transplants.
• Severe Communication or Cognitive Impairments: Participants with communication or cognitive disorders that would hinder their ability to participate in data collection, or those with aggressive behavioral disorders.
• Non-compliance or Medical Restrictions: Individuals unable to comply with study procedures or with medical conditions that prevent biological sample collection.
• \- Control Group: Healthy Individuals: Participants without ASD or any psychiatric or neurological disorders.
• Age and Gender Matching: Matched with the ASD group in terms of age, gender, and socio-demographic status.
• No History of Genetic or Neurodevelopmental Disorders: Individuals with no genetic syndromes, chromosomal anomalies, or neurodevelopmental disorders.
• No Chronic Disease History: Participants with no history of chronic diseases such as cancer, autoimmune diseases, or metabolic conditions.
• Informed Consent: Written informed consent from individuals over 18 years old or from parents/legal guardians for participants under 18.

Sponsors & Collaborators

• Research and Treatment Society of Genetic Disorders: lead
• İnvitrotek A.Ş.: collaborator
• Selcuk University: collaborator
• Istanbul Cerrahpasa Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Istanbul Medeniyet University Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Ankara SBÜ Gülhane Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Ankara Gazi Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Izmir Katip Çelebi Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Şanlıurfa Harran University Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Erzurum Atatürk University Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Trabzon Karadeniz Technical University Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Denizli Pamukkale University Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Gaziantep University, Department of Child and Adolescent Psychiatry: collaborator
• Afyonkarahisar University of Health Sciences, Faculty of Medicine, Department of Child and Adolescent Psychiatry: collaborator
• Uludag University: collaborator
• Giresun University, Department of Child and Adolescent Psychiatry: collaborator
• Baskent University: collaborator
• Istanbul Medeniyet University, Department of Psychiatry: collaborator
• Necmettin Erbakan University: collaborator
• Istanbul Çam and Sakura City Hospital, Department of Child and Adolescent Psychiatry: collaborator

Study Sites (20)

Konya Selcuk University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Konya, Selçuklu, 42250, Turkey (Türkiye)

Location

Konya Selcuk University Faculty of Medicine, Department of Psychiatry

Konya, Selçuklu, 42250, Turkey (Türkiye)

Location

Afyonkarahisar University of Health Sciences, Faculty of Medicine, Department of Child and Adolescent Psychiatry

Afyonkarahisar, Turkey (Türkiye)

Location

Ankara Başkent University, Department of Psychiatry

Ankara, Turkey (Türkiye)

Location

Ankara Gazi Faculty of Medicine, Department of Child and Adolescent Psychiatry

Ankara, Turkey (Türkiye)

Location

Ankara SBÜ Gülhane Faculty of Medicine, Department of Child and Adolescent Psychiatry

Ankara, Turkey (Türkiye)

Location

Bursa Uludağ University, Department of Child and Adolescent Psychiatry

Bursa, Turkey (Türkiye)

Location

Denizli Pamukkale University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Denizli, Turkey (Türkiye)

Location

Erzurum Atatürk University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Erzurum, Turkey (Türkiye)

Location

Gaziantep University, Department of Child and Adolescent Psychiatry

Gaziantep, Turkey (Türkiye)

Location

Giresun University, Department of Child and Adolescent Psychiatry

Giresun, Turkey (Türkiye)

Location

Istanbul Cerrahpasa Faculty of Medicine, Department of Child and Adolescent Psychiatry

Istanbul, Turkey (Türkiye)

Location

Istanbul Medeniyet University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Istanbul, Turkey (Türkiye)

Location

Istanbul Medeniyet University, Department of Psychiatry

Istanbul, Turkey (Türkiye)

Location

Istanbul Çam and Sakura City Hospital, Department of Child and Adolescent Psychiatry

Istanbul, Turkey (Türkiye)

Location

Izmir Katip Çelebi Faculty of Medicine, Department of Child and Adolescent Psychiatry

Izmir, Turkey (Türkiye)

Location

Konya Necmettin Erbakan University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Konya, Turkey (Türkiye)

Location

Konya Selcuk University Faculty of Medicine, Department of Medical Genetics

Konya, Turkey (Türkiye)

Location

Şanlıurfa Harran University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Sanliurfa, Turkey (Türkiye)

Location

Trabzon Karadeniz Technical University Faculty of Medicine, Department of Child and Adolescent Psychiatry

Trabzon, Turkey (Türkiye)

Location

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Biospecimen

Retention: SAMPLES WITH DNA

1. Venous Blood Samples: Analysis: These will be used for Whole Genome Sequencing (WGS), Whole Genome Bisulfite Sequencing (WGBS) for DNA methylation analysis, and RNA-Whole Transcriptome analysis to assess gene expression. 2. Nasal Swab Samples: Analysis: These will be utilized for Whole Genome Bisulfite Sequencing (WGBS) for methylation analysis and RNA-Whole Transcriptome analysis to explore tissue-specific gene expression profiles. 3. Serum or Plasma Samples (from venous blood, Not from all case-controls): Analysis: These samples will be used for ELISA to quantify protein levels, such as cytokines, growth factors, or other biomarkers of interest in ASD. Purpose: ELISA will provide insights into the biological effects of genetic and epigenetic changes by assessing the corresponding protein expression levels in the blood.

MeSH Terms

Conditions

Autism Spectrum Disorder; Genetic Risk Score

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Torabi, MD.,Ph.D.

  Selçuk Üniversitesi Tıp Fakültesi Tıbbi Genetik Anabilim Dalı

  STUDY CHAIR

• Ali Kandeğer, MD.

  RUH SAĞLIĞI VE HASTALIKLARI Uzmanı / Konya Selçuk Üniversitesi Tıp Fakültesi- Ruh Sağlığı ve Hastalıkları Anabilim Dalı Anabilim Dalı

  STUDY DIRECTOR

• Ömer Faruk Akça, MD.

  Çocuk Ve Ergen Ruh Sağlığı Ve Hastalıkları Uzmanı /Konya Necmettin Erbakan Üniversitesi Tıp Fakültesi- Çocuk ve Ergen Ruh Sağlığı ve Hastalıkları Anabilim Dalı

  STUDY DIRECTOR

• Nadir Koçak, MD

  Tıbbi Genetik Uzmanı / Konya Selçuk Üniversitesi Tıp Fakültesi- Tıbbi Genetik Anabilim Dalı ve Genetik Hastaliklar Araştırma ve Tedavi Derneği(RTSGD) Yönetim kurulu üyesi

  STUDY DIRECTOR

• Ebru Marzioğlu Özdemir, MD

  Tıbbi Genetik Uzmanı / Konya Selçuk Üniversitesi Tıp Fakültesi- Tıbbi Genetik Anabilim Dalı ve Genetik Hastaliklar Araştırma ve Tedavi Derneği(RTSGD) Yönetim kurulu üyesi

  STUDY DIRECTOR

• Özkan Bağcı, Ph.D.

  Tıbbi Genetik Uzmanı / Konya Selçuk Üniversitesi Tıp Fakültesi- Tıbbi Genetik Anabilim Dalı ve Genetik Hastaliklar Araştırma ve Tedavi Derneği(RTSGD) Yönetim kurulu üyesi

  STUDY DIRECTOR

Central Study Contacts

Rukiye Tekdemir, MD.

CONTACT

+90 530 326 49 95; dr.rtekdemir@gmail.com

Hasan Ali Güler, MD.

CONTACT

+90 505 347 29 66; dr.hasanaliguler@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: December 27, 2025
• Primary Completion (Estimated): December 27, 2027
• Study Completion (Estimated): May 27, 2028
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

TU (20)