UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036785
Receipt No. R000041919
Scientific Title Multicenter trial of performance of the gaze tracking device and diagnostic program (GF01) to diagnose autism spectrum disorder (ASD)
Date of disclosure of the study information 2019/05/23
Last modified on 2019/06/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter trial of performance of the gaze tracking device and diagnostic program (GF01) to diagnose autism spectrum disorder (ASD)
Acronym Multicenter trial of performance of the gaze tracking device and diagnostic program (GF01) to diagnose autism spectrum disorder (ASD)
Scientific Title Multicenter trial of performance of the gaze tracking device and diagnostic program (GF01) to diagnose autism spectrum disorder (ASD)
Scientific Title:Acronym Multicenter trial of performance of the gaze tracking device and diagnostic program (GF01) to diagnose autism spectrum disorder (ASD)
Region
Japan

Condition
Condition Autism spectrum disorder (ASD)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine efficacy (diagnostic performance) and safety of diagnosing with the gaze tracking device and diagnostic program (GF01) for subjects with suspected ASD or TD, compared to the results from the autism diagnostic interview.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 1. Sensitivity
Sensitivity = ASD diagnosed based on both ADOS-2 and GF01/ASD diagnosed based on ADOS-2
2. Specificity
Specificity = non-ASD diagnosed based on both ADOS-2 and GF01/non-ASD diagnosed based on ADOS-2
Key secondary outcomes Secondary endpoints
1. Positive predictive value
2. Negative predictive value
3. Correlation between each symptom of ASD and performance assessment
4. Visual function and performance assessment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The ADOS-2 examiner and an examiner using GF01 diagnose ASD based on the following procedures.
An examiner, pre-appointed by study site independently from an examiner using GF01, conducts the ADOS-2 assessment. Subjects will be classified as ASD, non-ASD, or TD. The results of ADOS-2 must be masked to any other people until completion of the test using GF01.
The subjects will be conducted the gaze tracking test by a pre-appointed examiner according to the operation procedure in a closed space separated by partitions. The results of A+, A, or B+ are considered as ASD, and B-, C, or C- as non-ASD.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
5 years-old <=
Age-upper limit
17 years-old >=
Gender Male and Female
Key inclusion criteria Children or adolescents with a suspected diagnosis of ASD: Group1
1. Aged 5 to 17 years at consent, male or female.
2. Referred from another facility because of suspicion of ASD or suspected ASD by a doctor who conducted a clinical interview initially.
3. Children or adolescents who can take all the scheduled checkups within 3 months from the day of the initial consultation at the study site.
4. Children or adolescents whose legally acceptable representative provided a written informed consent.

Typically developing children or adolescents: Group2
1. Aged 5 to 17 years at consent, male or female.
2. Recruited under conditions of not having neurodevelopmental disorders in the DSM-5 based on prior clinical information such as development history and medical history.
3. Children or adolescents who can take all the scheduled checkups within 3 months from the day of the initial consultation at the study site.
4. Children or adolescents whose legally acceptable representative provided a written informed consent.
Key exclusion criteria 1. Children or adolescents who cannot be obtained information about development in their toddlerhood from his/her legally acceptable representative.
2. Complication of schizophrenia in the DSM-5.
3. Cyclopia or visual dysfunctions such as severe myopia or hyperopia with difficulty in recognizing images on screen of the study device.
4. Antipsychotic treatment at consent.
5. Depression, severe anxiety, tension, or agitated state which immediately needs to start medical treatment.
6. Considered unable to keep steady during the gaze tracking test.
7. Children or adolescents who cannot take the scheduled checkups.
8. Serious physical disorder.
9. More than or equal to 90 percentile in the ADHD-RS-IV.
10. A total IQ less than 70.
11. Risk of aggravation of psychiatric symptoms or epileptic seizures triggered by using the study device.
12. Participation in another trial within a month from the day of providing of consent to this study.
13. Considered ineligible for inclusion in this study by the investigator.
Target sample size 196

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name J
Last name Tsuchiya
Organization Hamamatsu University School of Medicine
Division name Research Center for Child Mental Development
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL +81-53-435-2331
Email kj-tsuchiya@umin.net

Public contact
Name of contact person
1st name Keni
Middle name J
Last name Tsuchiya
Organization Hamamatsu University School of Medicine
Division name Research Center for Child Mental Development
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL +81-53-435-2331
Homepage URL
Email kj-tsuchiya@umin.net

Sponsor
Institute Hamamatsu University Hospital, Department of Psychiatry
Institute
Department

Funding Source
Organization JVC KENWOOD Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Hamamatsu University Hospital
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel +81-53-435-2850
Email rinri@hama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW 初回届出年月日: 2019年2月6日, 届出回数:1回

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 02 Month 28 Day
Date of IRB
2019 Year 01 Month 21 Day
Anticipated trial start date
2019 Year 05 Month 27 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 17 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041919

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.