NCT05020951

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 28, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

August 19, 2021

Last Update Submit

January 6, 2026

Conditions

Accurate and Complete Data Acquisition for Clinical Trials

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    18 months

Secondary Outcomes (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.

    18 months

Study Arms (1)

Laboratory Data

Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE

Other: Medidata RAVE

Interventions

Medidata RAVEOTHER

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.

Laboratory Data

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Study Officials

  • Tamara Miller, MD, MSCE

    Children's Healthcare of Atlanta/Emory University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

August 28, 2021

Primary Completion

July 31, 2023

Study Completion

March 31, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(8)