Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-01 @ 1:56 AM
Study NCT ID:
NCT01761695
Status:
TERMINATED
Last Update Posted:
2018-07-20
First Post:
2013-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Myelod Leukemia Registry at Asan Medical Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Bone marrow aspirate or peripheral blood (for its mononuclear cells) will be collected, processed, and cryopreserved for future analysis of DNA or cell culture. Acquisition of biospecimens will be proceeded if patient agree with the informed consent for donation of biospecimen to 'Asan Medical Center Biomaterial Resource Banking Center'. This registry data will be used as a basic demographic and clinical information for the biospecimens."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The PI resigned the institute. The rest investigators at the institute decided to terminate the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '30 years'}], 'secondaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': '30 years', 'description': "Definition of events will be as 'failure', 'progress to AP/BC', 'intolerant and medication change', and 'death from any cause'."}, {'measure': 'Failure-free survival', 'timeFrame': '30 years', 'description': 'Failure will be defined as BCR-ABL elevation at 2 serial times, progression to AP/BC, loss of hematologic / cytogenetic response, any appearance of ABL kinase mutation, and clonal evolution.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leukemia, Chronic Myeloid', 'Myeloid Leukemia, Chronic, Accelerated Phase', 'Myeloid Leukemia, Chronic, Chronic Phase']}, 'descriptionModule': {'briefSummary': 'The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.', 'detailedDescription': '1. Acquisition of informed concent form\n2. Data acquisition from medical record including\n\n * demographic / disease-associated factors\n * details of treatment, and its results\n * complications during treatment\n * genetic data\n * survival outcome (upto 30 years)\n3. Accumulation of data for 30 years\n4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are diagnosed and/or treated with chronic myeloid leukemia at Asan Medical Center, Seoul, Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are diagnosed and/or treated as chronic myeloid leukemia at Asan Medical Center\n* 15 years of age and over\n* All patients who give written consent according to guidelines at Asan Medical Center committee on human research\n\nExclusion Criteria:\n\n* Patients who refuse to give consent to registering'}, 'identificationModule': {'nctId': 'NCT01761695', 'briefTitle': 'Chronic Myelod Leukemia Registry at Asan Medical Center', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Prospective Observational Cohort Registry for Patients With Chronic Myeloid Leukemia at Asan Medical Center', 'orgStudyIdInfo': {'id': 'AMC-HEMREG-CML'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CML CP', 'description': 'Diagnosed as CML with chronic phase', 'interventionNames': ['Other: Diagnosed as CML']}, {'label': 'CML AP', 'description': 'Diagnosed as CML with accelerated phase', 'interventionNames': ['Other: Diagnosed as CML']}, {'label': 'CML BC', 'description': 'Diagnosed as CML with blast crisis', 'interventionNames': ['Other: Diagnosed as CML']}, {'label': 'CML other', 'description': 'Diagnosed as CML, which is not included in any of other category', 'interventionNames': ['Other: Diagnosed as CML']}], 'interventions': [{'name': 'Diagnosed as CML', 'type': 'OTHER', 'otherNames': ['Diagnosed as chronic myeloid leukemia'], 'description': 'All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047', 'armGroupLabels': ['CML AP', 'CML BC', 'CML CP', 'CML other']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae-Young Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dae-Young Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}