The Development of Diagnosis and Prognosis Predictive Mod... | NCT06843642

Studies
The Development of Diagnosis and Prognosis Predictive Model for Peripheral Nerve Disease

NCT06843642

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Feb 25, 2025Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

Peripheral Nerve Disease

Interventions

Not provided

Countries

China

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Feb 24, 2025

First Posted Date

Feb 25, 2025Actual

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

Feb 24, 2025

Last Update Posted Date

Feb 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Wuhan No.1 Hospital	OTHER
University Hospital Heidelberg	OTHER
West China Hospital	OTHER

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

This is a retrospective observational cohort study (MRN-PND), aiming to explore the utility of contrast-enhanced MRN (ceMRN) compared to plain MRN in diagnosing peripheral nerve diseases and predicting the prognosis of patients with these conditions. Additionally, artificial intelligence (AI) methods are employed to enhance the diagnostic accuracy of MRN for peripheral nerve diseases and to precisely predict disease outcomes.

Detailed Description

Not provided

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

10,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation analysis of MR information and diagnosis outcome	The indicator is the area under the curve of the predict diagnosis outcome.	0.5 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent MRN scanning at Wuhan Union Hospital between January 2015 and January 2025;
Age > 18 years;
Definitive clinical diagnosis (either healthy individuals or patients with a specific condition).

Exclusion criteria：

Poor quality of imaging;
Incomplete clinical data or loss to follow-up;
Unclear clinical diagnosis.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy People and Patients with Peripheral Nerve Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital，Tongji Medical College，Huazhong University of Science and Technology		Wuhan	Hubei	430000	China

Condition Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases

Ancestor Terms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided