Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 3:08 AM
Study NCT ID:
NCT02330718
Status:
UNKNOWN
Last Update Posted:
2019-02-22
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective and Retrospective Cohort Study to Find New Prognostic Factors and Therapeutic Targets in Patients With Newly Diagnosed or Relapsed Malignant Hematologic Disorder Excluding Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'peripheral blood and bone marrow aspirates have been collected and stored for the study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-31', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients with malignant hematologic disorders to examine the new prognostic factors and therapeutic targets', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Hematologic Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to elucidate the factors which are associated with the diagnosis and predict prognosis and therapeutic targets by collecting specimens of tissue sample, peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in patients with malignant hematologic disorders except acute leukemia. This study is eligible for patients who are diagnosed with malignant hematologic disorders except acute leukemia or who will have diagnostic procedure with suspicion of having hematologic malignancy. Prospective cohort is for patients who are not in treatment for hematologic malignancy. Retrospective cohort is for patients who are diagnosed and in treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed or relapsed malignant hematologic disorders except acute leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with malignant hematologic disorders except acute leukemia who are diagnosed pathologically according to the revised 2008 WHO classification of tumours of haematopoietic and lymphoid tissue or who will have diagnostic procedure with suspicion of having hematologic malignancy.\n* Any gender and age ≥ 19 years\n* Written informed consent\n* Diagnosed after 2005-01-01 in retrospective cohort group.\n\nExclusion Criteria:\n\n* Patients who cannot understand or disagree the informed consent\n* Patients who diagnosed with acute leukemia'}, 'identificationModule': {'nctId': 'NCT02330718', 'briefTitle': 'Prospective and Retrospective Cohort Study to Find New Prognostic Factors and Therapeutic Targets in Patients With Newly Diagnosed or Relapsed Malignant Hematologic Disorder Excluding Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0236'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Seok Kim, MD, Ph.D', 'role': 'CONTACT', 'phone': '82-2-2228-1972'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}