Recruiting NCT05590715
International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 12 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
Overview
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
Primary outcome measures
- Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. [Time frame: Day 0]
- Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations [Time frame: Day 0]
Eligibility criteria
Inclusion criteria
- Participants previously diagnosed with ASD (DSM-5)
- Available well-documented health records within the first 2 years of life
- Participants must have a parent or reliable caregiver who agrees to provide information about the participant
- Participants willing and consenting or assenting to participate.
Exclusion criteria
- Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
- If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- SARRC — Phoenix
- California Neuroscience Research — Sherman Oaks
- BioPhase Research — Miami
- The Angel Medical Research — Miami Lakes
- Rush University Medical Center — Chicago
- University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders — Columbia
- Golden Hearts Diagnostic — Alamogordo
- Red Oak Psychiatry Associates — Houston
- … and 1 more center
Spain · 7 centers
- Hospital General Universitario Dr Balmis — Alicante
- Hospital Clinic of Barcelona — Barcelona
- Hospital Infantil Universitario Nino Jesus (HIUNJS) — Madrid
- Hospital universitario Infanta Leonor — Madrid
- Hospital Universitario Puerta De Hierro Majadahonda — Majadahonda
- Policlina Gipuzkoa — San Sebastián
- Hospital Álvaro Cunqueiro — Vigo
Australia · 5 centers
- Children's Health Queensland Hospital and Health Service — South Brisbane
- Mater Misericordiae Limited — South Brisbane
- Flinders Medical Centre — Bedford Park
- Locuspsych — Melbourne
- Murdoch Children's Research Institute — Parkville
Identifiers
NCT: NCT05590715 · STA-B-001