NCT06222203|Recruiting
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Sponsor study identifier
Secondary identifiers
observational
225
1 country
1
Study Start
October 9, 2024
Actual (reported)Primary Completion
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2024
Actual (reported)January 24, 2024
Actual (reported)October 9, 2024
Actual (reported)December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Assess feasibility of the study algorithm in identifying atypical neurofibromas (ANs), atypical neurofibromatous neoplasms of unknown biologic potential (ANNUBPs), CDKN2A/B mutated lesions, and/or malignant peripheral nervous sheath tumors (MPNS...
Proportion of lesions that undergo surgical intervention (biopsy or resection) that are ANs, ANNUBPs, CDKN2A/B mutated lesions and/or MPNST
Throughout the study
Assess whether the proposed surveillance and management approach for participants with NF1 at high risk and low risk of MPNST is feasible
Throughout the study
Participants with clinical or genetic diagnosis of NF1 AND at least one of the eligibility-required high-risk characteristics
Participants with clinical or genetic diagnosis of NF1 AND none of the eligibility-required high-risk characteristic
Parents or guardians of participants 8-17 years old in High-Risk or Low-Risk Cohorts
Participants aged \>= 3 years old with a clinical or genetic diagnosis of NF1; parents or guardians of participants ages 8-17 years old.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Brigitte C Widemann, M.D.
National Cancer Institute (NCI)
First Submitted
January 23, 2024
First Posted
January 24, 2024
Study Start
October 9, 2024
Actual (reported)Primary Completion
December 31, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 2, 2026
Record last verified: 2026-08-28
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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Source: ClinicalTrials.gov.
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