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Natural History Study of Plexiform Neurofibromas in Patients With Neurofibromatosis Type 1
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00445991
  Purpose

RATIONALE: Following the growth of plexiform neurofibromas in patients with neurofibromatosis type 1 may help the study of cancer in the future.

PURPOSE: This natural history study is following the growth of plexiform neurofibromas in patients with neurofibromatosis type 1.


Condition Intervention
Neurofibromatosis Type 1 (nf1)
Precancerous/Nonmalignant Condition
 Procedure: magnetic resonance imaging

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies neurofibromatosis type 1 neurofibromatosis type 2
MedlinePlus related topics: Cancer MRI Scans Neurofibromatosis
U.S. FDA Resources
Study Type: Observational
Official Title: Natural History of Plexiform Neurofibromas in Neurofibromatosis Type 1 (NF1)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of growth of plexiform neurofibromas over 3 years
  • Usefulness of volumetric MRI tumor measurements

Study Start Date: November 2003
Detailed Description:

OBJECTIVES:

  • Document the rate of growth of plexiform neurofibromas over 3 years in patients with neurofibromatosis type1.
  • Evaluate the usefulness of volumetric MRI tumor measurements in these patients.

OUTLINE: This is a multicenter study.

Patients undergo blood sample collection at baseline. DNA from the samples is stored for possible future study. Patients undergo MRI at baseline and at 1 and 3 years and a physical examination every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets at least 2 of the following diagnostic criteria for neurofibromatosis type 1 (NF1):

    • At least 6 café-au-lait macules

      • At least 1.5 cm in postpubertal patients OR at least 0.5 cm in prepubertal patients
    • At least 2 neurofibromas of any type OR 1 or more plexiform neurofibroma
    • Freckling in the axilla or groin
    • Optic glioma (tumor of the optic pathway)
    • At least 2 Lisch nodules (benign iris hamartomas)
    • A distinctive bony lesion (either dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)
    • First-degree relative with NF1
  • Able to image tumor or define tumor margins by MRI
  • No more than 1 member of the same family may be enrolled on this study

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No metallic implant that would preclude MRI
  • No other medical or psychological condition that would preclude MRI or anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the site of plexiform neurofibroma

Surgery

  • More than 6 months since prior surgery involving the plexiform neurofibroma (excluding biopsy)

Other

  • No concurrent antineoplastic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445991

Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brigitte C. Widemann, MD NCI - Pediatric Oncology Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000349339, NCI-01-C-0027
Study First Received: March 7, 2007
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00445991  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neurofibromatosis type 1 (NF1)
plexiform neurofibroma

Study placed in the following topic categories:
Precancerous Conditions
Neurodegenerative Diseases
Neurofibromatosis type 1
Neurofibromatosis 1
Neoplastic Syndromes, Hereditary
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Neurofibroma
 Neuromuscular Diseases
Peripheral Nervous System Diseases
Neurofibromatoses
Peripheral Nervous System Neoplasms
Neurofibroma, Plexiform
Nerve Sheath Neoplasms
Nervous System Neoplasms
Neurocutaneous Syndromes

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009



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