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Combination of Predictive Biomarkers to Increase Diagnostics Efficiency of Autism Spectrum Disorder

NCT05796310 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2023-04-03

No results posted yet for this study

Summary

Early identification and diagnosis of autism spectrum disorder (ASD) is necessary to promote access to early treatment. Despite the high incidence, in Italy it is estimated that 1 in 77 children (age 7-9 years) (Narzisi et al., 2018), the diagnosis and the choice of rehabilitation treatment for patients with Autism Spectrum Disorder (ASD) are still based on clinical observation. In the absence of targeted pharmacological therapies, early surveillance and evaluation aimed at timely intervention represent the only successful strategy to reduce the severity of symptoms (Palomo R et al., 2006) and improve the quality of life of children affected by ASD and their families, thus also leading to a reduction in costs for the National Health Service (Ganz ML. 2007). However, compared to the great advances in neuroscience, the clinical management of autistic individuals is seriously lagging behind, and the disorder is often diagnosed after 3-4 years of age despite the presence of deficits starting from the very first months of life (Zwaigenbaum L et al. al., 2013). The aim of this project is to bridge the gap between research and clinic, thanks to the convergence of multiple biological and clinical data.

Conditions

Interventions

DIAGNOSTIC_TEST

Salivary collection

Collection of saliva via swab for miRNA processing

DIAGNOSTIC_TEST

eye-tracking recorder

Administration of eye-tracking session recording Saccadic Eye Movements, fixation duration and pupillary response.

DIAGNOSTIC_TEST

neuropsychological assessment

Administration of neuropsychological tests and collected patient medical history

Sponsors & Collaborators

  • Regione Sicilia

    collaborator UNKNOWN

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796310 on ClinicalTrials.gov