Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07444918
Description:
De-identified individual participant data (IPD) including demographic characteristics, treatment subgroup assignment (short/long course), efficacy outcomes (ORR, PFS, OS assessments per protocol), and safety data (adverse event records graded by NCI CTCAE v5.0) will be shared. All personally identifiable information (e.g., name, medical record numbers) will be removed to protect participant privacy. IPD sharing will be allowed after primary endpoint analysis (or study result publication), upon formal request by qualified researchers for legitimate medical research purposes, and subject to institutional review board (IRB) approval plus a signed data use agreement (DUA) (outlining data security/responsible use).
Study:
NCT07444918
Study Brief:
Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors