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NCT06222203
Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)
trial in Neurofibromatosis 1 in 225 participants. Currently enrolling.
31 December 2034
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 225 |
| Start date | 9 October 2024 |
| Primary completion | 31 December 2034 |
| Estimated completion | 31 December 2035 |
| Sites | 1 location across United States |
Conditions studied
- Neurofibromatosis 1 — all drugs for Neurofibromatosis 1 →
- Nerve Sheath Neoplasms — all drugs for Nerve Sheath Neoplasms →
Sponsor
National Cancer Institute (NCI)
Who can join
Adults 3 to 120, any sex, with Neurofibromatosis 1 or Nerve Sheath Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Early Detection of Malignant and Premalignant Peripheral Nerve Tumors Using Cell-Free DNA Fragmentomics.
Sundby RT, Szymanski JJ, Pan AC, Jones PA, et al · · 2024 · cited 14× · PMID 39093127 · DOI 10.1158/1078-0432.ccr-24-0797 -
Malignant peripheral nerve sheath tumors in neurofibromatosis type 1 arise from distinct nodular lesions: A retrospective imaging analysis.
Salamon J, Widemann BC, Gross AM, Baldwin A, et al · · 2025 · PMID 41473742 · DOI 10.1093/noajnl/vdaf201
Verify or expand the search:
- PubMed search for NCT06222203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neurofibromatosis 1
Currently open trials in the same condition.
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- NCT05913037 — FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas · Phase 3 · active not recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06222203 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 26 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06222203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing