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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04212351
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be between 1 day and 30 years of age, inclusive
2. Subjects must either meet clinical criteria for NF1 or have molecular genetic germ line evidence of NF1
3. Subject is able to have his/her blood sample drawn within a reasonable period of time after signing consent
4. Subjects must either have:
1. Active\* LGGs, no active PNs (Cohort 1)
2. Active\* PNs, no active LGGs (Cohort 2)
3. No active\* LGGs or PNs (Cohort 3) \*Active is defined as any LGG or PN that has shown growth (determined by MRI) in the past 12 months or is causing ongoing symptomatic visual, neurologic, or organ dysfunction or disfigurement as determined by the site investigator.
Exclusion Criteria:
1\. Patients with NF1 with evidence of both LGG and PN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
30 Years
Study:
NCT04212351
Study Brief:
Protocol Section:
NCT04212351