Detailed Result for NCT04478292
NCT ID: | NCT04478292 |
---|---|
NLM Download Date Description: | N/A |
Study First Submitted Date: | 2020-06-08 |
Last Update Submitted Date: | 2022-11-03 |
Last Update Submitted Date: | 2022-11-03 |
Result First Submitted Date: | N/A |
Disposition First Submitted Date: | N/A |
Start Month Year: | March 1, 2021 |
Start Date: | 2021-03-01 |
Start Date Type: | Actual |
Verification Month Year: | July 2022 |
Verification Date: | 2022-07-31 |
Completion Month Year: | September 30, 2027 |
Completion Date: | 2027-09-30 |
Completion Date Type: | Anticipated |
Primary Completion Month Year: | March 31, 2026 |
Primary Completion Date: | 2026-03-31 |
Primary Completion Date Type: | Anticipated |
Study first Submitted QC Date: | 2020-07-15 |
Study first posted Date: | 2020-07-20 |
Result first Submitted QC Date: | N/A |
Result First Posted Date: | N/A |
Disposition First Submitted QC Date: | N/A |
Disposition First Posted Date: | N/A |
Last Updated Submitted QC Date: | 2022-11-03 |
Last Updated Posted Date: | 2022-11-08 |
Target Duration: | N/A |
Study Type: | Interventional |
Acronym: | N/A |
Baseline Population: | N/A |
Brief Title: | A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy |
Official Title: | A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease |
Overall Status: | Recruiting |
Last Known Status: | N/A |
Phase: | Phase 3 |
Enrollment: | 330 |
Enrollment Type: | Anticipated |
Source: | Shanghai Children's Medical Center |
Limitation and Caveats: | N/A |
Number of Arms: | 4 |
Number of Groups: | N/A |
Why Stopped: | N/A |
Has Expanded Access: | N/A |
Expanded Access Type Individual: | N/A |
Expanded Access Type Intermediate: | N/A |
Expanded Access Type Treatment: | N/A |
Has DMC: | true |
Is it FDA Regulated Drug: | N/A |
Is it FDA Regulated Device: | N/A |
Is it Unapproved Device: | N/A |
Is PPSD: | N/A |
Is US Export: | N/A |
Is Biospec Retention: | N/A |
Biospec Description: | N/A |
Plan to Share IPD: | Yes |
Plan to Share IPD Description: | Study protocol, SAP and ICF were shared before study initiation. Patient data and the information about the process of the study will be shared within the 3 participants annually after enrollment patients. |
IPD Time Frame: | The data will be shared within the 3 hospital every 12 months after enrollment of patients. |
IPD Access Criteria: | Scheduled meeting and paper transferring. |
IPD URL: | N/A |