NCT06662591Not yet recruiting
Investigation of the Genetic and Environmental Causes of Autism: a Multi-Center Study
A Multi-Center Multi-Omics Approach for Investigating Genetic and Epigenetic Mechanisms in Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 29 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 24 Oct 2024
- Start date
- 27 Dec 2025
- Primary completion date
- 27 Dec 2027
- Lead sponsor
- Research and Treatment Society of Genetic Disorders
- Diseases
- Autism
- NCT number
- NCT06662591
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 27 Dec 2025 to the primary completion date, 27 Dec 2027
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \- 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.
Sex: All · Accepts healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Afyonkarahisar University of Health Sciences, Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Afyonkarahisar | Turkey (Türkiye) | Unknown status |
| Ankara Başkent University, Department of Psychiatry Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Gazi Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara SBÜ Gülhane Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Bursa Uludağ University, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Denizli Pamukkale University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Denizli | Turkey (Türkiye) | Unknown status |
| Erzurum Atatürk University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Erzurum | Turkey (Türkiye) | Unknown status |
| Gaziantep University, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Unknown status |
| Giresun University, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Giresun | Turkey (Türkiye) | Unknown status |
| Istanbul Cerrahpasa Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul Çam and Sakura City Hospital, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul Medeniyet University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul Medeniyet University, Department of Psychiatry Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Izmir Katip Çelebi Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Konya Selcuk University Faculty of Medicine, Department of Medical Genetics Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Konya Selcuk University Faculty of Medicine, Department of Psychiatry Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Konya Necmettin Erbakan University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Konya Selcuk University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Şanlıurfa Harran University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Sanliurfa | Turkey (Türkiye) | Unknown status |
| Trabzon Karadeniz Technical University Faculty of Medicine, Department of Child and Adolescent Psychiatry Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.