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Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.

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ClinicalTrials.gov Identifier: NCT02078401
Recruitment Status : Unknown
Verified July 2014 by Dr. Catherine Cassiman, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : March 5, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Catherine Cassiman, Universitaire Ziekenhuizen Leuven

Brief Summary:
The goal of this project is to get more insight into the (neuro)ophthalmological characteristics of children with neurofibromatosis type 1. This way investigators would like to update the current guidelines for follow up and treatment of optic pathway gliomas. Clinical findings will be compared with the results of Optical coherence tomography (OCT) and MRI (magnetic resonance imaging).

Condition or disease
Neurofibromatosis Type 1

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.
Study Start Date : April 2014
Estimated Primary Completion Date : August 2014


Group/Cohort
Neurofibromatosis type 1 children



Primary Outcome Measures :
  1. Visual acuity [ Time Frame: childhood (0 to 18y) ]
  2. Presence of optic pathway glioma [ Time Frame: childhood (0 to18y) ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with neurofibromatosis type 1 with and without optic pathway glioma
Criteria

Inclusion Criteria:

  • neurofibromatosis type 1

Exclusion Criteria:

  • no neurofibromatosis type 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078401


Contacts
Contact: Catherine Cassiman, MD 00321632660 catherine.cassiman@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Catherine Cassiman, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Catherine Cassiman, MD Universitaire Ziekenhuizen Leuven

Responsible Party: Dr. Catherine Cassiman, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02078401     History of Changes
Other Study ID Numbers: S56406
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014

Keywords provided by Dr. Catherine Cassiman, Universitaire Ziekenhuizen Leuven:
Optic pathway glioma
Ophthalmological screening

Additional relevant MeSH terms:
Glioma
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Neoplasms by Site
Cranial Nerve Diseases
Optic Nerve Diseases
Eye Diseases