Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-02 @ 1:26 AM
Study NCT ID:
NCT04944732
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007562', 'term': 'Creutzfeldt-Jakob Syndrome'}], 'ancestors': [{'id': 'D017096', 'term': 'Prion Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-27', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical manifestations', 'timeFrame': '1 year', 'description': 'Clinical manifestations of patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Creutzfeldt Jakob Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Creutzfeldt Jakob disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Creutzfeldt Jakob disease\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04944732', 'briefTitle': 'Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Follow up Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease (WS / T 562-2017)', 'orgStudyIdInfo': {'id': 'M2020331'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Creutzfeldt Jakob disease', 'description': 'Patients with Creutzfeldt Jakob disease', 'interventionNames': ['Diagnostic Test: laboratory examination, auxiliary examination, pathological results']}], 'interventions': [{'name': 'laboratory examination, auxiliary examination, pathological results', 'type': 'DIAGNOSTIC_TEST', 'description': '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)', 'armGroupLabels': ['Patients with Creutzfeldt Jakob disease']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Li Xiaogang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}