Autism Spectrum DisorderNCT05796310
Combination of Predictive Biomarkers to Increase Diagnostics Efficiency of Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Salivary collection, eye-tracking recorder and neuropsychological assessment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2022to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Child
Study population: Patients with the following characteristics will be recruited: 1. a cohort of at least 25 outpatients with Autism Spectrum Disorder (diagnosed According to Diagnostic and Statistical Manual of Mental Disorders 5 criteria), aged between 4 and 17 years; 2. a cohort of at least 25 healthy sibs of enrolled autistic patients, aged 4 to 17 years; 3. a cohort of a minimum of 25 healthy controls, aged between 4 and 17 years, matched by sex and age to the ASD patients recruited (+/- 3 years).
Autistic Spectrum Disorder patients, Inclusion Criteria:
- aged between 4 and 17years;
- Autism Spectrum Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
- healthy brothers/sisters, aged 4 to 17 years;
- adequate ocular vision, i.e. absence of objective eye problems such as double vision, cataracts, etc.;
- ability to maintain position in front of the monitor, i.e. knowing how to maintain or regain posture independently or with the help of postural aids;
- cognitive skills appropriate to the task such as being able to recognize images.
ASD siblings and Typical Developmental children, Inclusion Criteria
- aged between 4 and 17years;
- typical development, absence of known pathologies;
- adequate ocular vision, i.e. absence of objective eye problems such as double vision, cataracts, etc.;
- ability to maintain position in front of the monitor, i.e. knowing how to maintain or regain posture independently or with the help of postural aids;
- cognitive skills appropriate to the task such as being able to recognize images.
Autistic Spectrum Disorder patients, Exclusion Criteria:
- age not between 4 years and 17 years;
- difficulty in controlling ocular motility and visual hookup;
- unavailability of at least one sibling to participate in the diagnostic process;
- subjects with a syndromic phenotype or for which the presence of a known genetic syndrome has already been ascertained (e.g. Syndrome Rett, Xfra, Tuberous Sclerosis, etc.).
ASD siblings and Typical Developmental children, Exclusion Criteria:
- age not between 4 years and 17 years;
- subjects diagnosed with moderate/severe intellectual disability, or affected by known neurological pathologies (infantile cerebral palsy, epilepsy, sensory deficits) or with a history of preterm birth (≤32w) or underweight (≤10°ile for gestational age);
- subjects with a syndromic phenotype or for which the presence of a known genetic syndrome has already been ascertained (e.g. Syndrome Rett, Xfra, Tuberous Sclerosis, etc.);
- difficulty in controlling ocular motility and visual hookup;
- subjects suffering from neurodevelopmental disorders or family history for ASD for the control group.
Trial locations and contacts
1 site in 1 country.
IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle neuro-fragilità contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98100
IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle neuro-fragilità, 09060128256, info@irccsme.it
About this study
Official title: Mind the Gap: a Bridge Between Research and Clinic for the Prevention and Diagnosis of Autism Spectrum Disorders
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.
Read the detailed description
The purpose of this project is to combine multiple biological levels of information and their matching with the clinical phenotype and personal/family anamnesis of the single individual. In fact, by stratifying multiple levels of biomarkers, including behavioral (eye tracking), clinical and neuropsychological variables, parameters taken from transcriptomics (RNAseq), the goal is to identify a panel of intermediate biomarkers capable of (a) distinguishing autistic subjects from typically developing brothers/sisters, (b) to distinguish autistic subjects from typically developing subjects, (c) to stratify autistic patients into a limited number of homogeneous subgroups by physiopathology, in order to allow personalized pharmacology and improve their management clinic.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Salivary collection, eye-tracking recorder, neuropsychological assessment
- Keywords
- Autism, miRNA, Eye Tracker, biomarkers
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary collectionDiagnostic test
Collection of saliva via swab for miRNA processing
eye-tracking recorderDiagnostic test
Administration of eye-tracking session recording Saccadic Eye Movements, fixation duration and pupillary response.
neuropsychological assessmentDiagnostic test
Administration of neuropsychological tests and collected patient medical history
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder Patients | This group is comprised of 3-17 years children with an expert clinical diagnosis of autism spectrum disorders. Receives: Diagnostic Test: Salivary collection; Diagnostic Test: eye-tracking recorder; Diagnostic Test: neuropsychological assessment | |
| Siblings of children with Autism Spectrum Disorders | This group is comprised of 3-17 years old siblings, with typical development, of a child with an expert clinical diagnosis of autism spectrum disorders. Receives: Diagnostic Test: Salivary collection; Diagnostic Test: eye-tracking recorder | |
| Typical Development children | This group is comprised of 3-17 years children with typical development. Receives: Diagnostic Test: Salivary collection; Diagnostic Test: eye-tracking recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary miRNA profile
Measures of salivary miRNA profile - identify the microRNAs differentially expressed in patients with autism spectrum disorder compared to sibling and healthy controls.
Measured: At time of enrollment
eye-gaze path characteristics - Saccadic Eye Movements
Saccadic eye movement assessments measure the speed and accuracy of a participant's saccadic eye movements in response to various stimuli.
Measured: At time of enrollment
eye-gaze path characteristics - fixation time
Total fixation duration measurements in pre-selected areas (areas of interest)
Measured: At time of enrollment
eye-gaze path characteristics - pupillary response
pupillary response measurements assess the changes of mean pupil diameters for the left and right eyes after exposition to pre-selected immages (areas of interest)
Measured: At time of enrollment
Secondary outcomes (3)
Autism Diagnostic Observation Schedule 2 (ASD patients only)
Ados2 is a semi-structured, standardised assessment to measure autistic behaviors.
Measured: At time of enrollment
Vineland Adaptive Behavior Scales (VABS) II (ASD patients only)
The VABS II is a standardized semi-structured interview to measure adaptive behavior.
Measured: At time of enrollment
Intellectual Quotient (ASD patients only)
Intellectual quotient measured using one cognitive test per subject, chosen depending on age and language development (either Griffiths Developmental Rating Scales, Wechsler Intelligence Scale for Children - Fourth Edition, or Leiter III).
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start28 Jul 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Sicilia
- Responsible party
- Principal investigator, Francesca Cucinotta, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796310
- Sponsor's protocol ID
- SPECTRUM01
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ander BP, Barger N, Stamova B, Sharp FR, Schumann CM. Atypical miRNA expression in temporal cortex associated with dysregulation of immune, cell cycle, and other pathways in autism spectrum disorders. Mol Autism. 2015 Jun 19;6:37. doi: 10.1186/s13229-015-0029-9. eCollection 2015.
PubMed 26146533Frazier TW, Coury DL, Sohl K, Wagner KE, Uhlig R, Hicks SD, Middleton FA. Evidence-based use of scalable biomarkers to increase diagnostic efficiency and decrease the lifetime costs of autism. Autism Res. 2021 Jun;14(6):1271-1283. doi: 10.1002/aur.2498. Epub 2021 Mar 8.
PubMed 33682319Frazier TW, Klingemier EW, Parikh S, Speer L, Strauss MS, Eng C, Hardan AY, Youngstrom EA. Development and Validation of Objective and Quantitative Eye Tracking-Based Measures of Autism Risk and Symptom Levels. J Am Acad Child Adolesc Psychiatry. 2018 Nov;57(11):858-866. doi: 10.1016/j.jaac.2018.06.023. Epub 2018 Sep 13.
PubMed 30392627Frazier TW, Strauss M, Klingemier EW, Zetzer EE, Hardan AY, Eng C, Youngstrom EA. A Meta-Analysis of Gaze Differences to Social and Nonsocial Information Between Individuals With and Without Autism. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):546-555. doi: 10.1016/j.jaac.2017.05.005. Epub 2017 May 11.
PubMed 28647006Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.
PubMed 17404130Ghahramani Seno MM, Hu P, Gwadry FG, Pinto D, Marshall CR, Casallo G, Scherer SW. Gene and miRNA expression profiles in autism spectrum disorders. Brain Res. 2011 Mar 22;1380:85-97. doi: 10.1016/j.brainres.2010.09.046. Epub 2010 Sep 21.
PubMed 20868653Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x.
PubMed 27105825Hicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018.
PubMed 30473705Leblond CS, Le TL, Malesys S, Cliquet F, Tabet AC, Delorme R, Rolland T, Bourgeron T. Operative list of genes associated with autism and neurodevelopmental disorders based on database review. Mol Cell Neurosci. 2021 Jun;113:103623. doi: 10.1016/j.mcn.2021.103623. Epub 2021 Apr 29.
PubMed 33932580Mor M, Nardone S, Sams DS, Elliott E. Hypomethylation of miR-142 promoter and upregulation of microRNAs that target the oxytocin receptor gene in the autism prefrontal cortex. Mol Autism. 2015 Aug 14;6:46. doi: 10.1186/s13229-015-0040-1. eCollection 2015.
PubMed 26273428Narzisi A, Costanza C, Umberto B, Filippo M. Non-pharmacological treatments in autism spectrum disorders: an overview on early interventions for pre-schoolers. Curr Clin Pharmacol. 2014 Feb;9(1):17-26. doi: 10.2174/15748847113086660071.
PubMed 24050743Narzisi A, Posada M, Barbieri F, Chericoni N, Ciuffolini D, Pinzino M, Romano R, Scattoni ML, Tancredi R, Calderoni S, Muratori F. Prevalence of Autism Spectrum Disorder in a large Italian catchment area: a school-based population study within the ASDEU project. Epidemiol Psychiatr Sci. 2018 Sep 6;29:e5. doi: 10.1017/S2045796018000483.
PubMed 30187843Palomo R, Belinchon M, Ozonoff S. Autism and family home movies: a comprehensive review. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S59-68. doi: 10.1097/00004703-200604002-00003.
PubMed 16685187Sarachana T, Zhou R, Chen G, Manji HK, Hu VW. Investigation of post-transcriptional gene regulatory networks associated with autism spectrum disorders by microRNA expression profiling of lymphoblastoid cell lines. Genome Med. 2010 Apr 7;2(4):23. doi: 10.1186/gm144.
PubMed 20374639Zwaigenbaum L, Bryson S, Garon N. Early identification of autism spectrum disorders. Behav Brain Res. 2013 Aug 15;251:133-46. doi: 10.1016/j.bbr.2013.04.004. Epub 2013 Apr 12.
PubMed 23588272
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind the Gap: a Bridge Between Research and Clinic for the Prevention and Diagnosis of Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05796310
- Acronym / sponsor ID
- SPECTRUM01
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, miRNA, Eye Tracker, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Collaborators
- Regione Sicilia
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this project is to combine multiple biological levels of information and their matching with the clinical phenotype and personal/family anamnesis of the single individual. In fact, by stratifying multiple levels of biomarkers, including behavioral (eye tracking), clinical and neuropsychological variables, parameters taken from transcriptomics (RNAseq), the goal is to identify a panel of intermediate biomarkers capable of (a) distinguishing autistic subjects from typically developing brothers/sisters, (b) to distinguish autistic subjects from typically developing subjects, (c) to stratify autistic patients into a limited number of homogeneous subgroups by physiopathology, in order to allow personalized pharmacology and improve their management clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder Patients | – | Diagnostic Test: Salivary collection, Diagnostic Test: eye-tracking recorder, Diagnostic Test: neuropsychological assessmentThis group is comprised of 3-17 years children with an expert clinical diagnosis of autism spectrum disorders. |
| Siblings of children with Autism Spectrum Disorders | – | Diagnostic Test: Salivary collection, Diagnostic Test: eye-tracking recorderThis group is comprised of 3-17 years old siblings, with typical development, of a child with an expert clinical diagnosis of autism spectrum disorders. |
| Typical Development children | – | Diagnostic Test: Salivary collection, Diagnostic Test: eye-tracking recorderThis group is comprised of 3-17 years children with typical development. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with the following characteristics will be recruited: 1. a cohort of at least 25 outpatients with Autism Spectrum Disorder (diagnosed According to Diagnostic and Statistical Manual of Mental Disorders 5 criteria), aged between 4 and 17 years; 2. a cohort of at least 25 healthy sibs of enrolled autistic patients, aged 4 to 17 years; 3. a cohort of a minimum of 25 healthy controls, aged between 4 and 17 years, matched by sex and age to the ASD patients recruited (+/- 3 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary collectionCollection of saliva via swab for miRNA processing | Diagnostic test | Autism Spectrum Disorder Patients, Siblings of children with Autism Spectrum Disorders, Typical Development children |
| eye-tracking recorderAdministration of eye-tracking session recording Saccadic Eye Movements, fixation duration and pupillary response. | Diagnostic test | Autism Spectrum Disorder Patients, Siblings of children with Autism Spectrum Disorders, Typical Development children |
| neuropsychological assessmentAdministration of neuropsychological tests and collected patient medical history | Diagnostic test | Autism Spectrum Disorder Patients |
Primary outcome
Salivary miRNA profile
Time frame: At time of enrollment
Measures of salivary miRNA profile - identify the microRNAs differentially expressed in patients with autism spectrum disorder compared to sibling and healthy controls.
eye-gaze path characteristics - Saccadic Eye Movements
Time frame: At time of enrollment
Saccadic eye movement assessments measure the speed and accuracy of a participant's saccadic eye movements in response to various stimuli.
eye-gaze path characteristics - fixation time
Time frame: At time of enrollment
Total fixation duration measurements in pre-selected areas (areas of interest)
eye-gaze path characteristics - pupillary response
Time frame: At time of enrollment
pupillary response measurements assess the changes of mean pupil diameters for the left and right eyes after exposition to pre-selected immages (areas of interest)
3 secondary outcomes
Autism Diagnostic Observation Schedule 2 (ASD patients only)
Time frame: At time of enrollment
Vineland Adaptive Behavior Scales (VABS) II (ASD patients only)
Time frame: At time of enrollment
Intellectual Quotient (ASD patients only)
Time frame: At time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 26146533Ander BP, Barger N, Stamova B, Sharp FR, Schumann CM. Atypical miRNA expression in temporal cortex associated with dysregulation of immune, cell cycle, and other pathways in autism spectrum disorders. Mol Autism. 2015 Jun 19;6:37. doi: 10.1186/s13229-015-0029-9. eCollection 2015.
- Background: PubMed 33682319Frazier TW, Coury DL, Sohl K, Wagner KE, Uhlig R, Hicks SD, Middleton FA. Evidence-based use of scalable biomarkers to increase diagnostic efficiency and decrease the lifetime costs of autism. Autism Res. 2021 Jun;14(6):1271-1283. doi: 10.1002/aur.2498. Epub 2021 Mar 8.
- Background: PubMed 30392627Frazier TW, Klingemier EW, Parikh S, Speer L, Strauss MS, Eng C, Hardan AY, Youngstrom EA. Development and Validation of Objective and Quantitative Eye Tracking-Based Measures of Autism Risk and Symptom Levels. J Am Acad Child Adolesc Psychiatry. 2018 Nov;57(11):858-866. doi: 10.1016/j.jaac.2018.06.023. Epub 2018 Sep 13.
- Background: PubMed 28647006Frazier TW, Strauss M, Klingemier EW, Zetzer EE, Hardan AY, Eng C, Youngstrom EA. A Meta-Analysis of Gaze Differences to Social and Nonsocial Information Between Individuals With and Without Autism. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):546-555. doi: 10.1016/j.jaac.2017.05.005. Epub 2017 May 11.
- Background: PubMed 17404130Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.
- Background: PubMed 20868653Ghahramani Seno MM, Hu P, Gwadry FG, Pinto D, Marshall CR, Casallo G, Scherer SW. Gene and miRNA expression profiles in autism spectrum disorders. Brain Res. 2011 Mar 22;1380:85-97. doi: 10.1016/j.brainres.2010.09.046. Epub 2010 Sep 21.
- Background: PubMed 27105825Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x.
- Background: PubMed 30473705Hicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018.
- Background: PubMed 33932580Leblond CS, Le TL, Malesys S, Cliquet F, Tabet AC, Delorme R, Rolland T, Bourgeron T. Operative list of genes associated with autism and neurodevelopmental disorders based on database review. Mol Cell Neurosci. 2021 Jun;113:103623. doi: 10.1016/j.mcn.2021.103623. Epub 2021 Apr 29.
- Background: PubMed 26273428Mor M, Nardone S, Sams DS, Elliott E. Hypomethylation of miR-142 promoter and upregulation of microRNAs that target the oxytocin receptor gene in the autism prefrontal cortex. Mol Autism. 2015 Aug 14;6:46. doi: 10.1186/s13229-015-0040-1. eCollection 2015.
- Background: PubMed 24050743Narzisi A, Costanza C, Umberto B, Filippo M. Non-pharmacological treatments in autism spectrum disorders: an overview on early interventions for pre-schoolers. Curr Clin Pharmacol. 2014 Feb;9(1):17-26. doi: 10.2174/15748847113086660071.
- Background: PubMed 30187843Narzisi A, Posada M, Barbieri F, Chericoni N, Ciuffolini D, Pinzino M, Romano R, Scattoni ML, Tancredi R, Calderoni S, Muratori F. Prevalence of Autism Spectrum Disorder in a large Italian catchment area: a school-based population study within the ASDEU project. Epidemiol Psychiatr Sci. 2018 Sep 6;29:e5. doi: 10.1017/S2045796018000483.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle neuro-fragilità contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cucinotta, MD, PhD (09060128256, francesca.cucinotta@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary miRNA profile (time frame: At time of enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796310, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.