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NCT05677594 · ClinicalTrials.gov registry record
Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1
A clinical trial of Neurofibromatosis 1 and Atypical Neurofibroma, sponsored by Johns Hopkins University.
- Active
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT05677594: Active study of Neurofibromatosis 1 and Atypical Neurofibroma, sponsored by Johns Hopkins University.
NCT05677594 is a study of Neurofibromatosis 1 and Atypical Neurofibroma that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 80 participants, below the 1,032-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05677594, a study of Neurofibromatosis 1 and Atypical Neurofibroma, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this prospective observational study is to learn about the utility of imaging and clinical features in patients with Neurofibromatosis type 1 categorized as high risk for the development of malignant peripheral nerve sheath tumors. The main objectives are: * To evaluate the prevalence, multi-parametric imaging features of distinct nodular lesions ("DNLs") and natural history in people with NF1 with clinical and genetic features deemed "high-risk" for malignancy. * To assess the relationship between individual clinical, genetic and imaging factors that have been suggested to be risk factors for malignant peripheral nerve sheath tumors (MPNST) and the confirmation of atypical neurofibromas (aNF)/ atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) or MPNST on pathology. In this research study, the participants will be asked to undergo whole body MRI, provide blood sample and clinical evaluation annually.
Primary Outcome
Prevalence of distinct nodular lesions in people with NF1 associated pNF and clinical or genetic factors that are hypothesized to be "high risk" for MPNST
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Whole Body Magnetic Resonance Imaging
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2028-06-30 |
What the registry record for NCT05677594 still lists
NCT05677594 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,032-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 1 intervention - of which Whole Body Magnetic Resonance Imaging is the first listed.
NCT05677594 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05677594 about?
NCT05677594 is a clinical study titled "Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1". The goal of this prospective observational study is to learn about the utility of imaging and clinical features in patients with Neurofibromatosis type 1 categorized as high risk for the development of malignant peripheral nerve sheath tumors. The main objectives are: * To evaluate the prevalence,...
What is the current status of trial NCT05677594?
This trial is currently active not recruiting. The enrollment target is 80 participants. The study started on 2021-07-01. Estimated completion is 2028-06-30.
What conditions does trial NCT05677594 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Atypical Neurofibroma, Malignant Peripheral Nerve Sheath Tumor (MPNST) of Soft Tissue (Diagnosis).
What interventions are being tested in trial NCT05677594?
The interventions under investigation include: Whole Body Magnetic Resonance Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05677594?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05677594 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05677594's enrollment target sits among peer trials
80 13th of 24 higher than 12 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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