Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05020951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.', 'timeFrame': '18 months', 'description': 'Thorough evaluation of the data extraction and transfer process from each participating site to the PBTC and PEP-CTN databases. Establish feasibility of the proposed process at each site as well as the operations cores.'}], 'secondaryOutcomes': [{'measure': 'Identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.', 'timeFrame': '18 months', 'description': 'Laboratory results identified through automated extraction and transfer will be evaluated to determine if all laboratory results submitted as part of the therapeutic study can be identified.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accurate and Complete Data Acquisition for Clinical Trials']}, 'descriptionModule': {'briefSummary': "An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE that is housed within each consortium's Uniform Resource Locator (URL). This study will assess efficiency, effectiveness, and scalability of the laboratory data extraction and transfer processes. This study will identify factors in the process that impact consortium operations, central protocol activation and implementation to the point of declaring the site data-ready.", 'detailedDescription': 'PRIMARY OBJECITVES\n\nI. To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.\n\nSECONDARY OBJECTIVES\n\nI. To identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Laboratory data from patients previously enrolled on selected PEP-CTN and PBTC trials. Studies include ADVL1412, ADVL1312, ADVL1411, PBTC-042, PBTC-047 (Stratum 1), PBTC-050, and PBTC-051.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient Data Inclusion Criteria: Specific patient clinical research data to be included in this study for retrospective data capture and analysis will originate from the following PEP-CTN and PBTC studies:\n\n* PEP-CTN: ADVL1412, ADVL1312, ADVL1411\n* PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)\n\nParticipating Site Inclusion Criteria: Data from above clinical studies at the following institutions will be included in the initial pilot, with potential to expand to other sites at which patients on these studies were treated.\n\n* Site Participation: Children's Healthcare of Atlanta - Scottish Rite and Egleston, Children's Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, Seattle Children's Hospital, St. Jude Children's Research Hospital, Texas Children's Hospital, and University of California, San Francisco - Mission Bay"}, 'identificationModule': {'nctId': 'NCT05020951', 'briefTitle': 'Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave', 'orgStudyIdInfo': {'id': 'PEPN21EHR'}, 'secondaryIdInfos': [{'id': 'PCTC-N15', 'type': 'OTHER', 'domain': 'Pediatric Brain Tumor Consortium (PBTC)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laboratory Data', 'description': "Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE", 'interventionNames': ['Other: Medidata RAVE']}], 'interventions': [{'name': 'Medidata RAVE', 'type': 'OTHER', 'description': 'Data collection done exclusively through Medidata Rave. Medidata Rave is a clinical data management system being used for data collection for this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role assignments.', 'armGroupLabels': ['Laboratory Data']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Tamara Miller, MD, MSCE', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Healthcare of Atlanta/Emory University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Pediatric Brain Tumor Consortium', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}