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Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE

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ClinicalTrials.gov Identifier: NCT05020951
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pediatric Brain Tumor Consortium
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment
Accurate and Complete Data Acquisition for Clinical Trials Other: Medidata RAVE

Detailed Description:

PRIMARY OBJECITVES

I. To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.

SECONDARY OBJECTIVES

I. 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.

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Study Type : Observational
Estimated Enrollment : 118 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
Estimated Study Start Date : August 23, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Group/Cohort Intervention/treatment
Laboratory Data
Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE
Other: Medidata RAVE
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.




Primary Outcome Measures :
  1. Test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC. [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 18 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Laboratory data from patients previously enrolled on a subset of PEP-CTN and PBTC trials. Studies include ADVL1412, ADVL1312, ADVL1411, PBTC-042, PBTC-047 (Stratum 1), PBTC-050, and PBTC-051.
Criteria

Inclusion Criteria:

Patient 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:

  • PEP-CTN: ADVL1412, ADVL1312, ADVL1411
  • PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)

Participating 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.

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020951


Contacts
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Contact: Tamara Miller, MD, MSCE (404)-727-9268 tamara.miller@emory.edu

Locations
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United States, California
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Kieuhoa Vo, MD MAS    415-476-3831    kieuhoa.vo@ucsf.edu   
Principal Investigator: Arun Rangaswami, MD         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jason Fangusaro, MD    404-727-5012    jfangus@emory.edu   
Principal Investigator: William Cash, MD MSc         
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tobey MacDonald, MD    404-727-1447    tobey.macdonald@emory.edu   
Principal Investigator: Tobey MacDonald, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Julia Glade Bender, MD    212-639-6729    gladebej@mskcc.org   
Principal Investigator: Christopher Forlenza, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theodore Laetsch, MD    214-771-6530    laetscht@chop.edu   
Principal Investigator: Frank Balis, MD         
United States, Tennessee
Saint Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne Furman, MD    901-595-2403    wayne.furman@stjude.org   
Principal Investigator: Wayne Furman, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Patricia Baxter, MD    832-824-4681    pabaxter@texaschildrens.org   
Contact: Murali Chintagumpala, MD    (832) 822-4266    mxchinta@texaschildrens.org   
Principal Investigator: Patricia Baxter, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Navin Pinto, MD    206-987-5783    navin.pinto@seattlechildrens.org   
Principal Investigator: Sarah Leary, MD         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Pediatric Brain Tumor Consortium
Investigators
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Study Chair: Tamara Miller, MD, MSCE Children's Healthcare of Atlanta/Emory University
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT05020951    
Other Study ID Numbers: PEPN21EHR
PCTC-N15 ( Other Identifier: Pediatric Brain Tumor Consortium (PBTC) )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No