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Studying genes and environment in autism across age groups

Studies genetic and environmental factors that may contribute to autism in people.

Key facts

Who runs it
Research and Treatment Society of Genetic Disorders
Where
Afyonkarahisar, Ankara, Bursa, Denizli, Erzurum, Gaziantep, Giresun, Istanbul, Izmir, Konya, Sanliurfa, and Trabzon, TürkiyeSee the 20 sites
Trial code
Registry title
Investigation of the Genetic and Environmental Causes of Autism: a Multi-Center Study
Status
Not yet recruiting
People taking part
3,000 people, planned
Started
27 Dec 2025
Expected to end
27 May 2028
Type of study
Observational, 3 groups
Record updated
29 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with autism spectrum disorder or clear autism traits, and also healthy people without any psychiatric or neurological disorder as a comparison group.

Sex
All sexes can join.
Disease stage
Autism spectrum disorder diagnosed by DSM-5 criteria, or significant autism traits without a formal diagnosis. All functional levels, from high-functioning to low-functioning, can join. ADHD and learning disabilities alongside autism are allowed.
Earlier treatment
People with earlier gene or cell therapy, frequent blood transfusions, or bone marrow transplants cannot join.

Main reasons for not taking part

  • Severe psychotic disorders such as schizophrenia or schizoaffective disorder
  • Known genetic syndromes or chromosomal anomalies, such as Down syndrome or Fragile X syndrome
  • Communication or cognitive problems, or aggressive behavior, that would stop data collection
  • Cannot follow the study steps, or has a medical condition that prevents taking biological samples
  • Healthy group: any chronic disease such as cancer, autoimmune disease or metabolic disease

The registry criteria, word for word

Show all 3 criteriaShow less

Other criteria

  • Inclusion Criteria: Autism Spectrum Disorder (ASD) or Autism-like Traits: Individuals diagnosed with ASD based on DSM-5 diagnostic criteria, or those displaying significant autism traits without a formal diagnosis; 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; Comorbid Conditions: Inclusion of volunteers with developmental profiles and comorbid conditions such as ADHD and learning disabilities; Informed Consent: Written informed consent from participants over 18 years of age. For participants under 18, consent from parents or legal guardians
  • Exclusion Criteria: Severe Psychotic Disorders: Individuals diagnosed with conditions like schizophrenia or schizoaffective disorder; 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

Where in Türkiye

  • Afyonkarahisar University of Health Sciences, Faculty of Medicine, Department of Child and Adolescent PsychiatryAfyonkarahisar, TürkiyeContact: Aziz Kara, MD.No longer taking part
  • Ankara Başkent University, Department of PsychiatryAnkara, TürkiyeContact: Yasemin Hoşgören Alıcı, MD.No longer taking part
  • Ankara Gazi Faculty of Medicine, Department of Child and Adolescent PsychiatryAnkara, TürkiyeContact: Yasemin Taş Torun, MD.No longer taking part
  • Ankara SBÜ Gülhane Faculty of Medicine, Department of Child and Adolescent PsychiatryAnkara, TürkiyeContact: Mehmet Ayhan Cöngöloğlu, MD.No longer taking part
  • Bursa Uludağ University, Department of Child and Adolescent PsychiatryBursa, TürkiyeContact: Caner Mutlu, MD.No longer taking part
  • Denizli Pamukkale University Faculty of Medicine, Department of Child and Adolescent PsychiatryDenizli, TürkiyeContact: Bürge Kabukçu Başay, MD.No longer taking part
  • Erzurum Atatürk University Faculty of Medicine, Department of Child and Adolescent PsychiatryErzurum, TürkiyeContact: Esen Yıldırım Demirdöğen, MD.No longer taking part
  • Gaziantep University, Department of Child and Adolescent PsychiatryGaziantep, TürkiyeContact: Mehmet Karadağ, MD.No longer taking part
  • Giresun University, Department of Child and Adolescent PsychiatryGiresun, TürkiyeContact: Bedia Sultan Önal, MD.No longer taking part
  • Istanbul Çam and Sakura City Hospital, Department of Child and Adolescent PsychiatryIstanbul, TürkiyeContact: Yasin Çalışkan, MD.No longer taking part
  • Istanbul Cerrahpasa Faculty of Medicine, Department of Child and Adolescent PsychiatryIstanbul, TürkiyeContact: Mahmut Cem Tarakçıoğlu, MDNo longer taking part
  • Istanbul Medeniyet University Faculty of Medicine, Department of Child and Adolescent PsychiatryIstanbul, TürkiyeContact: Alperen Bıkmazer, MDNo longer taking part
  • Istanbul Medeniyet University, Department of PsychiatryIstanbul, TürkiyeContact: Aynur Görmez, MD.No longer taking part
  • Izmir Katip Çelebi Faculty of Medicine, Department of Child and Adolescent PsychiatryIzmir, TürkiyeContact: Gonca Özyurt, MD.No longer taking part
  • Konya Necmettin Erbakan University Faculty of Medicine, Department of Child and Adolescent PsychiatryKonya, TürkiyeContact: Ömer Faruk Akça, MD.No longer taking part
  • Konya Selcuk University Faculty of Medicine, Department of Child and Adolescent PsychiatryKonya, TürkiyeContact: Hasan Ali Güler, MD.No longer taking part
  • Konya Selcuk University Faculty of Medicine, Department of Medical GeneticsKonya, TürkiyeContact: Nadir Koçak, MD.No longer taking part
  • Konya Selcuk University Faculty of Medicine, Department of PsychiatryKonya, TürkiyeContact: ALİ KANDEĞER, MD.No longer taking part
  • Şanlıurfa Harran University Faculty of Medicine, Department of Child and Adolescent PsychiatrySanliurfa, TürkiyeContact: Fethiye Kılıçaslan, MD.No longer taking part
  • Trabzon Karadeniz Technical University Faculty of Medicine, Department of Child and Adolescent PsychiatryTrabzon, TürkiyeContact: Esra Hoşoğlu, MD.No longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multi-Center Multi-Omics Approach for Investigating Genetic and Epigenetic Mechanisms in Autism Spectrum Disorder
Plain-language title
Studying genes and environment in autism across age groupsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 October 2024