Multicenter Study on Rehabilitation Medical Data for Pedi... | NCT06367920

Studies
Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development

NCT06367920

Sponsor

Bundang CHA Hospital

Status

Recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Pediatric ALL
Healthy

Interventions

Magnetic Resonance Imaging, Behavioral assessments

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 11, 2024

First Submission Date that Met QC Criteria

Apr 11, 2024

First Posted Date

Apr 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging, Behavioral assessments	Diagnostic Test	Magnetic Resonance Imaging, Behavioral assessments

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain magnetic resonance imaging	MRI scan is a process of measuring anatomical changes of brain and tract fiber	A time point at which imaging was performed between January 1, 2010 and December 31, 2024

Secondary Outcomes

Measure	Description	Time Frame
Medical records	Medical records including basic characteristics and behavioral assessments	A time point at which recording medical examinations was performed between January 1, 2010 and December 31, 2024

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the Department of Rehabilitation Medicine at our hospital from January 2010 to December 2023 (patients who underwent brain MRI tests to determine the cause of developmental delay)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the Department of Rehabilitation Medicine at our hospital from January 2010 to December 2023 (patients who underwent brain MRI tests to determine the cause of developmental delay)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
So young Choi, BS	Contact	+82 031 780 6003	6003	csy505@chamc.co.kr

Overall Officials

Name	Affiliation	Role
Minyoung Kim, M.D., Ph.D.	Bundang CHA Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHA Bundang Medical Center, CHA University	Recruiting	Seongnam-si	Gyeonggi-do	463-712	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided