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

StatusTerminated
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Stopped Trial terminated Sponsor's reason: Funding for the project ended and all analyses have been completed Final enrollment: 46 participants (planned 118)v12 Show 1 more changeShow less
    • Final enrollment: 46 participants (planned 118)
  2. Minor Completion pushed from Mar 31, 2026 to Jun 30, 2026v11
  3. Minor Completion date: Sep 30, 2025 to Mar 31, 2026v10
  4. Minor Primary completion date changed from estimate of Sep 30, 2024 to Jul 31, 2023 Completion date: Sep 30, 2024 to Sep 30, 2025v9 Show 1 more changeShow less
    • Completion date: Sep 30, 2024 to Sep 30, 2025
  5. Notable Primary and study completion dates: Sep 30, 2023 to Sep 30, 2024v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 8 of 8 sitesv6 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  3. Notable Primary endpoint revisedv5 See this version in full on ClinicalTrials.gov ↗
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Start date changed from estimate of Aug 23, 2021 to Aug 28, 2021v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Site details revised at 8 of 8 sitesv2 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05020951
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI), Pediatric Brain Tumor Consortium
Conditions Accurate and Complete Data Acquisition for Clinical Trials
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov