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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\- 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 un…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Finalization of Clinical Data Recruitment
Timeframe: Expected to complete within 24 months of study initiation.
Trial details
NCT IDNCT06662591
SponsorResearch and Treatment Society of Genetic Disorders