Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-03 @ 8:17 PM
Study NCT ID:
NCT02401932
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-08', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophagocytosis']}, 'descriptionModule': {'briefSummary': 'Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.', 'detailedDescription': 'This is a retrospective study comparing malignant and non-malignant disorders associated bone marrow hemophagocytosis. The medical record of patients who had documented evidences of hemophagocytosis in bone marrow are reviewed. The clinical and biological characteristics are compared according to the underlying disorders of hemophagocytosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators reviewed the electronic data base of medical records at the Samsung Medical Center, and selected 264 patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy between January 2000 and June 2014.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy\n\nExclusion Criteria:\n\n* patients who did not evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy'}, 'identificationModule': {'nctId': 'NCT02401932', 'briefTitle': 'Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison of Malignant and Non-malignant Disorders Associated Bone Marrow Hemophagocytosis: A Single Center Experience', 'orgStudyIdInfo': {'id': '2015-02-013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemophagocytosis', 'description': 'The group includes patients who have the evidence of hemophagocytosis in their bone marrow or other sites.', 'interventionNames': ['Other: Hemophagocytosis']}], 'interventions': [{'name': 'Hemophagocytosis', 'type': 'OTHER', 'description': 'Best supportive care and immunosuppressive treatments', 'armGroupLabels': ['Hemophagocytosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seok Jin Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}