Evaluation of Diagnostic Criteria for Creutzfeldt Jakob D... | NCT04944732

Studies
Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease

NCT04944732

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jun 30, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Creutzfeldt Jakob Disease

Interventions

laboratory examination, auxiliary examination, pathological results

Countries

Not provided

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

Jun 2021

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, 2000Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jun 27, 2021

First Posted Date

Jun 30, 2021Actual

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

Jun 27, 2021

Last Update Posted Date

Jun 30, 2021Actual

Name	Class
Centers for Disease Control and Prevention, China	OTHER_GOV

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

Clinicians know little about Creutzfeldt Jakob disease, and they are not proficient in the diagnostic criteria of Creutzfeldt Jakob disease, so it is easy to misdiagnose or delay the diagnosis. As a rare central nervous system disease, it is necessary, feasible and practical to evaluate the diagnostic criteria of Creutzfeldt Jakob disease.

Detailed Description

To master the clinical application of the diagnosis of Creutzfeldt Jakob disease (WS / T 562-2017) and the problems in the implementation process; The rationality, practicability and operability of the diagnostic criteria were evaluated scientifically; Reduce the misdiagnosis rate; To provide clinical basis and suggestions for further improving the diagnostic criteria. Through consulting the literature of Creutzfeldt Jakob disease, the clinical manifestations, laboratory examination, auxiliary examination and pathological results of Creutzfeldt Jakob disease were analyzed and compared with the current diagnostic criteria; The clinical diagnosis and misdiagnosis of Creutzfeldt Jakob disease were analyzed; To train medical staff at all levels to apply the diagnostic criteria of Creutzfeldt Jakob disease, and to discuss the clinical cases of Creutzfeldt Jakob disease in many hospitals.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Creutzfeldt Jakob disease		Patients with Creutzfeldt Jakob disease	Diagnostic Test: laboratory examination, auxiliary examination, pathological results

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory examination, auxiliary examination, pathological results	Diagnostic Test	Personal information (sex, age), medical history of present disease, past medical history, family history, symptoms and signs, supplementary examination items (including laboratory examination, impact examination)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical manifestations	Clinical manifestations of patients	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Creutzfeldt Jakob disease

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Creutzfeldt Jakob disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li Xiaogang	Peking University Third Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007562	Creutzfeldt-Jakob Syndrome

Ancestor Terms

ID	Term
D017096	Prion Diseases
D002494	Central Nervous System Infections
D007239	Infections
D003704	Dementia

Browse Leaves

Not provided

Browse Branches

Not provided