UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036785 |
|---|---|
| Receipt number | 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 | 2024/01/22 13:30:03 |
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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
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
kj-tsuchiya@umin.net
Sponsor or person
Institute
Hamamatsu University Hospital, Department of Psychiatry
Institute
Department
Personal name
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
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
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
228
Results
NA
Results date posted
| 2024 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041919
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