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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2014 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Catherine Cassiman, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02078401
First received: February 26, 2014
Last updated: July 1, 2014
Last verified: July 2014
  Purpose
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
Neurofibromatosis Type 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: childhood (0 to 18y) ] [ Designated as safety issue: No ]
  • Presence of optic pathway glioma [ Time Frame: childhood (0 to18y) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neurofibromatosis type 1 children

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Dr. Catherine Cassiman, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02078401     History of Changes
Other Study ID Numbers: S56406 
Study First Received: February 26, 2014
Last Updated: July 1, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Optic pathway glioma
Ophthalmological screening

Additional relevant MeSH terms:
Neurofibromatosis 1
Glioma
Neurofibromatoses
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 Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Neoplasms by Site
Cranial Nerve Diseases
Optic Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2016