Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT02344966
Status:
UNKNOWN
Last Update Posted:
2019-03-18
First Post:
2014-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2014-12-30', 'studyFirstSubmitQcDate': '2015-01-18', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10years', 'description': 'Overall survival (OS) is defined as the time from date of diagnosis until death due to any cause within the follow-up period. Surviving patients are censored at date of last contact.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '10years', 'description': 'Progression-free survival (PFS) is defined as survival without disease progression or relapse; patients alive without disease progression or relapse are censored on the last assessment date. Median OS and PFS are calculated using Kaplan-Meier estimates with a 95% confidence interval.'}, {'measure': 'Treatment-related mortality', 'timeFrame': '10years', 'description': 'Treatment-related mortality was defined as death unrelated to refractory or progressive disease occurring before first remission was achieved, or any death in complete remission'}, {'measure': 'Complete remission rate', 'timeFrame': '10 years', 'description': 'Response assessment is performed according to the criteria reported by BD Cheson et al. (Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Leukemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the prognostic factors of acute leukemia patients and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during diagnosis process, treatment and/or thereafter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sampling is performed in patients diagnosed with acute leukemia in Severance Hospital.\n\nEvery eligible patients in peroid of study are enrolled. Patients must have the ability and willingness to sign a written informed consent document. Planned number of patients is 1100 considering annual incidence rate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute leukemia in Severance Hospital.\n* Both genders of 16 Years and older\n* sign a written informed consent document\n\nExclusion Criteria:\n\n* No comprehension or willingness to sign a written informed consent document.'}, 'identificationModule': {'nctId': 'NCT02344966', 'briefTitle': 'Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2010-0732'}}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JUNE-WON CHEONG, MD', 'role': 'CONTACT', 'email': 'JWCHONG70@yuhs.ac', 'phone': '82-2-2228-1970'}], 'facility': 'Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JUNE-WON CHEONG, MD', 'role': 'CONTACT', 'email': 'JWCHONG70@yuhs.ac', 'phone': '82-2-2228-1970'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}