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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT06222203
Eligibility Criteria:
* INCLUSION CRITERIA:
High-Risk and Low-Risk NF1 Cohorts
* Age \>= 3 years old
* Participants with clinical or genetic diagnosis of NF1.
* Participants with a diagnosis of mosaic or segmental NF1 are also eligible.
* Individuals may have (High-Risk Cohort) or not have (Low-Risk Cohort) at least one of the following characteristics:
* Microdeletion or 844-848 missense variants or other variants associated with increased risk of malignant peripheral nervous sheath tumor (MPNST)
* Family history of MPNST / atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) / atypical neurofibromas (ANF)
* Personal history of MPNST/ANNUBP/ANF or neurofibroma with CDKN2A loss
* Prior radiation therapy at any site
* Large plexiform neurofibroma (PN) burden (\>= 350 mL)
* Presence \>= 1 DNL at baseline
* The ability of the individual, parent/guardian or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document for participation.
EXCLUSION CRITERIA:
High-Risk and Low-Risk NF1 Cohorts
\- Inability or unwillingness to undergo MRI imaging
INCLUSION CRITERIA:
Parent Cohort
* Parent or guardian of pediatric individuals (8-17 years old) in High-Risk or Low-Risk Cohorts.
* The ability of the parent/guardian or LAR to understand and the willingness to sign a written consent document for parent/guardian participation in this study.
EXCLUSION CRITERIA:
Parent Cohort
\- None.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
120 Years
Study:
NCT06222203
Study Brief:
Protocol Section:
NCT06222203