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ACTIVE NOT RECRUITING
NCT05581511

Natural History Study of Cutaneous Neurofibromas in People With NF1

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

People diagnosed with NF1 may develop cutaneous neurofibromas, also known as cNFs. These benign tumors can cause discomfort and affect a person's quality of life. Researchers at Johns Hopkins are studying how cNF tumors form, grow and change over time. This information may help doctors in the future, provide early interventions and improve quality of life for NF1 patients. Researchers will also explore a new way of monitoring cNF with 3D camera technology. People of all ages with NF1, living in the United States, are invited to participate in this important research study.

Official title: Natural History Study of Cutaneous Neurofibromas in People With Neurofibromatosis Type 1

Key Details

Gender

All

Age Range

1 Year - 100 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2021-06-28

Completion Date

2029-06-30

Last Updated

2025-10-14

Healthy Volunteers

Not specified

Interventions

OTHER

Evaluation of the natural history of cutaneous neurofibromas

Cutaneous neurofibromas (cNFs) are the most common tumors in people with neurofibromatosis type 1 (NF1). Despite their benign histology, they can significantly impact patients' quality of life (QoL). In this project, the natural history of cNFs will be prospectively and systematically studied. To accomplish this, the reproducibility and efficiency of using 3D whole-body photography was evaluated in a small cohort of patients. The study is enrolling patients of all ages with cNFs into groups by epochs of life to characterize the baseline tumor burden and the change in number and morphology of cNFs over five years. In addition, the study will perform next generation sequencing to describe the genetic variations in the NF1 gene and evaluate potential relations between genotype and phenotype. Lastly, the study will validate clinician- and patient-reported severity scales of cNFs developed for this patient population.

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States