Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Arun Rangaswami, MD

Description

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.

Official Title

Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave

Details

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.

Keywords

Accurate and Complete Data Acquisition for Clinical Trials Medidata RAVE Laboratory Data

Eligibility

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

Locations

  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Seattle Children's Hospital accepting new patients
    Seattle Washington 98105 United States

Lead Scientist at UCSF

  • Arun Rangaswami, MD
    Professor, Pediatrics. Authored (or co-authored) 25 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT05020951
Study Type
Observational
Last Updated