Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-31 @ 12:54 PM
Study NCT ID:
NCT04157569
Status:
RECRUITING
Last Update Posted:
2020-02-25
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'venipuncture peripheral blood bone marrow finger stick peripheral blood saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative incidence of relapse(CIR)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cumulative incidence of relapse'}], 'secondaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia']}, 'descriptionModule': {'briefSummary': 'This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL', 'detailedDescription': 'This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population include old AML patients with somatic mutations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Male\n* not pregnant female\n* patients \\>=60 years old\n* Diagnosis of acute leukemia\n\nExclusion Criteria:\n\n* Pregnancy\n* HIV positive\n* patients \\>=100 years old'}, 'identificationModule': {'nctId': 'NCT04157569', 'briefTitle': 'CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia', 'orgStudyIdInfo': {'id': 'NavyGHB-006'}}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liren Qian, M.D.', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066957676'}], 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liren Qian, MD', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066957676'}], 'overallOfficials': [{'name': 'Liren Qian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Liren Qian', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}