Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT03595969
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Mitochondrial DNA Content and Risk of Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative copy number of mitochondrial DNA', 'timeFrame': 'From date of admission until the date of discharging from hospital, assessed up to 5 days', 'description': 'The ratio of mitochondrial DNA contents to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from chronic lymphocytic leukemiawhen compared with control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mitochondrial DNA'], 'conditions': ['Lymphoblastic Leukemia in Children']}, 'descriptionModule': {'briefSummary': 'Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of acute lymphoblastic leukemia (ALL).The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "A total of 150 eligible chronic lymphocytic leukemia patients were anticipated to include in this study. Moreover, 50 healthy controls without previous cancer history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.histological confirmed chronic lymphocytic leukemia; 2.preparing for chemotherapy; 3.no preoperative anticancer treatment.\n\nExclusion Criteria:\n\n* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT03595969', 'briefTitle': 'Association Between Mitochondrial DNA Content and Risk of Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Association Between Mitochondrial DNA Content and Risk of Acute Leukemia in Young Adult', 'orgStudyIdInfo': {'id': 'YL2018070101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute leukemia group', 'description': '150 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy', 'interventionNames': ['Diagnostic Test: Relative copy number of mitochondrial DNA']}, {'label': 'Control group', 'description': "The 50 healthy controls without previous cancer history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment.", 'interventionNames': ['Diagnostic Test: Relative copy number of mitochondrial DNA']}], 'interventions': [{'name': 'Relative copy number of mitochondrial DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Mitochondria are responsible for multiple cellular functions including regulation of energy production, modulation of oxidation-reduction status, generation of reactive oxygen species and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome comprised of independently replicating double stranded DNA (mtDNA).', 'armGroupLabels': ['Control group', 'acute leukemia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Xiao-Fan Zhu', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Lipeng Liu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}