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:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT06882057
Description:
1. Demographic Data: Age, sex, and other relevant baseline characteristics.
2. Treatment Information: Data on interventions received by participants, including dosage, treatment cycles, and duration.
3. Outcome Measures: Detailed information on primary and secondary outcome measures, such as response rates, survival rates, adverse events, and any the pre-specified endpoints.
4. Adverse Events: Data on all reported adverse events, including severity, duration, and outcome.
5. Laboratory Data: Results from laboratory tests, such as blood counts, biochemical markers, or molecular analysis.
6. Medical History: Pre-existing conditions, comorbidities, and prior treatments or interventions.
7. Vital Signs: relevant physiological data.
8. Efficacy and Safety Data: Any data relating to the efficacy (e.g., event-free survival) and safety (e.g., adverse effects) of the treatment.
Study:
NCT06882057
Study Brief:
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol