NCT02078401

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

February 26, 2014

Last Update Submit

July 1, 2014

Conditions

Neurofibromatosis Type 1

Keywords

Optic pathway gliomaOphthalmological screening

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

    childhood (0 to 18y)

  • Presence of optic pathway glioma

    childhood (0 to18y)

Study Arms (1)

Neurofibromatosis type 1 children

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with neurofibromatosis type 1 with and without optic pathway glioma

You may qualify if:

  • neurofibromatosis type 1

You may not qualify if:

  • no neurofibromatosis type 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Neurofibromatosis 1

Condition Hierarchy (Ancestors)

NeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Catherine Cassiman, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Cassiman, MD

CONTACT

00321632660catherine.cassiman@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 5, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

BE(1)