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NCT06222203 · ClinicalTrials.gov registry record
Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)
A clinical trial of Neurofibromatosis 1 and Nerve Sheath Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 225
- Enrollment target
- 1
- Study location
NCT06222203: Recruiting study of Neurofibromatosis 1 and Nerve Sheath Neoplasms, sponsored by National Cancer Institute (NCI).
NCT06222203 is a study of Neurofibromatosis 1 and Nerve Sheath Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 225 participants, below the 1,026-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06222203, a study of Neurofibromatosis 1 and Nerve Sheath Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 225 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Neurofibromatosis type 1 (NF1) is a genetic disease that can cause many symptoms. About half of people with NF1 will develop benign (noncancerous) tumors along nerves in the skin, brain, and other parts of the body. Sometimes, though, these tumors can become cancerous. Researchers do not yet know how to predict which tumors will become cancerous. Objective: To test a new method for predicting which benign NF1 tumors will become cancerous. Eligibility: People aged 3 years and older with a clinical or genetic diagnosis of NF1. Design: * Participants will be screened with a review of their medical history. All participants will have a baseline visit. They will have bood tests and imaging scans. They will have a physical exam. They will answer questions about their family history. Participants aged 8 years and older will take tests of their thinking skills and their emotional health. * Some participants may be asked to undergo more tests. These may include another type of imaging scan and a biopsy: A small sample of tissue may be removed from the tumor. * Participants will be divided into two groups: those believed to be at low risk and those believed to be at high risk of developing cancer. * Participants in the high-risk group will be asked to return for their next visit in 1 month to 3 years. * Participants in the low-risk group will be asked to return for their next visit in 6 months to 5 years. * Participants may also have follow-up visits by phone throughout the study. They will be in the study for 10 years.
Primary Outcome
Proportion of lesions that undergo surgical intervention (biopsy or resection) that are ANs, ANNUBPs, CDKN2A/B mutated lesions and/or MPNST
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2035-12-31 |
What NCT06222203 shows while recruiting
NCT06222203 is an observational study that tracks outcomes without assigning an intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,026-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 0 interventions.
NCT06222203 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06222203 about?
NCT06222203 is a clinical study titled "Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)". Background: Neurofibromatosis type 1 (NF1) is a genetic disease that can cause many symptoms. About half of people with NF1 will develop benign (noncancerous) tumors along nerves in the skin, brain, and other parts of the body. Sometimes, though, these tumors can become cancerous. Researchers do no...
What is the current status of trial NCT06222203?
This trial is currently recruiting. The enrollment target is 225 participants. The study started on 2024-10-09. Estimated completion is 2035-12-31.
What conditions does trial NCT06222203 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Nerve Sheath Neoplasms.
Who is sponsoring clinical trial NCT06222203?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06222203 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
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Where NCT06222203's enrollment target sits among peer trials
225 7th of 24 higher than 18 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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