Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PCTC-N15 | Other Identifier | Pediatric Brain Tumor Consortium (PBTC) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Pediatric Brain Tumor Consortium | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboratory Data | Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medidata RAVE | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 18 months |
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tamara Miller, MD, MSCE | Children's Healthcare of Atlanta/Emory University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States | ||
| Children's Healthcare of Atlanta - Egleston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39586036 | Derived | Miller TP, Getz KD, Krause E, Jo YG, Charapala S, Gramatages MM, Rabin K, Scheurer ME, Wilkes JJ, Fisher BT, Aplenc R. Automated Electronic Health Record Data Extraction and Curation Using ExtractEHR. JCO Clin Cancer Inform. 2024 Nov;8:e2400100. doi: 10.1200/CCI.24.00100. Epub 2024 Nov 25. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |