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NCT04212351 · ClinicalTrials.gov registry record
Frameshift Peptides of Children With NF1
A clinical trial, sponsored by Children's National Research Institute.
- Completed
- Registry status
- 60
- Enrollment target
NCT04212351: Completed study, sponsored by Children's National Research Institute.
NCT04212351 is a clinical trial that has completed, run by Children's National Research Institute. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04212351 has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study Summary
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.
Primary Outcome
All samples will be assayed on the FSP arrays consisting of peptides representing the frameshifts tumors can make in RNA processing. The amount of IgG bound to each feature will be determined as florescent intensity generated by bound secondary antibody. The mean intensity across the 20 subjects for each peptide for each of the 3 groups will be determined. All peptides in the NF1+LGG group with mean intensities greater than 3 SD higher than the mean of the NF1-LGG/PN group will be determined. Th
Interventions
- GENETIC Frameshift Array blood sample test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2022-04-27 |
What the finished NCT04212351 record still lists
NCT04212351 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Frameshift Array blood sample test is the first listed.
NCT04212351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04212351 about?
NCT04212351 is a clinical study titled "Frameshift Peptides of Children With NF1". 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 framesh...
What is the current status of trial NCT04212351?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2019-04-11. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT04212351?
The interventions under investigation include: Frameshift Array blood sample test (GENETIC).
Who is sponsoring clinical trial NCT04212351?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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