Clinical trial · Observational
Frameshift Peptides of Children With NF1
Frameshift Peptides of Children With Neurofibromatosis Type 1 (NF1) and Either Low-Grade Gliomas or Plexiform Neurofibromas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to determine if children and young adults with Neurofibromatosis Type 1 (NF1) and either Low Grade Gliomas (LGGs) or Plexiform Neurofibromas (PNs) have a specific frameshift peptide protein profile and whether a disease specific vaccine created to address these frameshift mutations and variants can be developed. Three study populations will be analyzed; patients with NF1 and active LGGs, NF1 and active PNs, and NF1 and no evidence of active LGGs or PNs. Participation involves a onetime blood draw.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frameshift Array blood sample test | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Patients with NF1 and active LGGs
- description
- Patients with Neurofibromatosis Type 1 with clinical or radiographic evidence of low grade glioma but no clinical or radiographic evidence of plexiform neurofibroma.
- interventionNames
- Genetic: Frameshift Array blood sample test
- label
- Patients with NF1 and active PNs
- description
- Patients with Neurofibromatosis Type 1 with clinical or radiographic evidence of plexiform neurofibroma but no clinical or radiographic evidence of low grade glioma.
- interventionNames
- Genetic: Frameshift Array blood sample test
- label
- Patients with NF1 with no active LGGs or PNs
- description
- Patients with Neurofibromatosis Type 1 with no clinical or radiographic evidence of both active plexiform neurofibroma and active low grade glioma.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
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