Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT03199859
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnosis and Treatment Standardization of Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium Rating Scale-98', 'timeFrame': 'Till 1 year after surgery', 'description': 'Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium'}], 'secondaryOutcomes': [{'measure': 'Functional assessment of cancer therapy - gastric cancer', 'timeFrame': 'Till 1 year after surgery', 'description': 'Quality of life measuring tool for gastric cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'postoperative', 'subsyndromal delirium', 'quality of life'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': '1. Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors\n2. Design a guideline for delirium, diagnosis or treatment', 'detailedDescription': 'The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.\n\nSecond, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Curable malignant gastric cancer\n\nExclusion Criteria:\n\n* Gastrointestinal stromal tumor\n* Uncurable cancer'}, 'identificationModule': {'nctId': 'NCT03199859', 'briefTitle': 'Early Diagnosis and Treatment Standardization of Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Early Diagnosis and Treatment Standardization of Delirium', 'orgStudyIdInfo': {'id': '072016105'}}, 'contactsLocationsModule': {'locations': [{'zip': '16801', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bong-Jin Hahm', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}