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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00693394 |
RATIONALE: Gathering health information about patients with neurofibromatosis type 1 over time may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying changes over time in patients with neurofibromatosis type 1 and their healthy siblings.
Condition | Intervention |
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Bone Cancer Brain and Central Nervous System Tumors Precancerous/Nonmalignant Condition Sarcoma |
Drug: fludeoxyglucose F 18 Procedure: cognitive assessment Procedure: digital image analysis Procedure: gene expression analysis Procedure: magnetic resonance imaging Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Study Type: | Observational |
Official Title: | Natural History Study and Longitudinal Assessment of Children, Adolescents, and Adults With Neurofibromatosis Type 1 |
Estimated Enrollment: | 200 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo a comprehensive baseline evaluation including clinical phenotyping, genotyping, imaging of tumor manifestations, and pain, quality of life, neuropsychological, motor, and endocrine evaluations. Unaffected siblings (controls) also undergo some of these evaluations.
Skin and tumor manifestations are evaluated with a variety of imaging techniques including digital photography, volume photography, digital dermoscopy, fludeoxyglucose F 18-positron emission tomography (FDG-PET), and MRI. In addition, patients undergo evaluation for pain, neuropsychological function, motor function, and endocrine abnormalities.
Cognitive and social-emotional function are evaluated at baseline and then periodically in patients and unaffected siblings (controls).
Patients are followed for NF1 manifestations periodically ranging from every six months to every three years for approximately 10 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosed with neurofibromatosis type 1 (NF1)* with ≥ 2 or more of the following diagnostic criteria:
If participating in the evaluation for variation in gene expression, patient must meet the following criteria:
PATIENT CHARACTERISTICS:
Must meet 1 of the following age criteria:
Must be able to obtain an MRI scan
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000589012, NCI-08-C-0079, NCI-P07283 |
Study First Received: | June 6, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00693394 |
Health Authority: | Unspecified |
bone cancer precancerous/nonmalignant condition untreated childhood visual pathway glioma adult neurofibrosarcoma childhood neurofibrosarcoma |
plexiform neurofibroma spinal cord neurofibroma adult pilocytic astrocytoma adult soft tissue sarcoma childhood soft tissue sarcoma |
Bone Neoplasms Precancerous Conditions Malignant mesenchymal tumor Bone neoplasms Central Nervous System Neoplasms Healthy Neurodegenerative Diseases Bone Diseases Neurofibromatosis 1 Soft tissue sarcomas Neoplasms, Connective and Soft Tissue Heredodegenerative Disorders, Nervous System Musculoskeletal Diseases Neurofibroma |
Neuromuscular Diseases Glioma Neurofibroma, Plexiform Nervous System Neoplasms Neurocutaneous Syndromes Astrocytoma Neurofibromatosis type 1 Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Peripheral Nervous System Diseases Neurofibromatoses Sarcoma Nerve Sheath Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nervous System Diseases |