Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT04505995
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following:
1. somatic mutation in PTPN11
2. somatic mutation in KRAS
3. somatic mutation in NRAS and HbF % \> 5x normal value for age
4. clinical diagnosis of neurofibromatosis Type 1.
Exclusion Criteria:
* 1\. Any condition that would prevent the subject from participating in the study.
2\. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study.
3\. Any condition that confounds the ability to interpret data from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT04505995
Study Brief:
Protocol Section:
NCT04505995