Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children
DOPANUR
Interventional Controlled Cross-sectional Study Assessing the Correlation Between Optic Nerve Vessels Anomalies, Serum Angiogenic Factors and Renal Anomalies in Children With Down Syndrome.
1 other identifier
interventional
200
1 country
1
Brief Summary
In approximately half of individuals with Down syndrome, an higher than normal number of vessels cross the optic disc margin. Investigator hypothesize that early retinal vessel branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin, an angiogenesis inhibitor encoded on chromosome 21. Since angiogenesis is critical in the development of eyes and other organs angiogenesis depended (specially kidney, brain, and recently described lungs and heart), early branching of retinal vessels at the level of the optic disc would also likely result in abnormal renal and other organs development in these individuals. Investigator wish to determine whether observation of optic disc vessels may serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs anomalies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
1 active site
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
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 5, 2018
July 1, 2018
1.5 years
June 27, 2017
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
correlation coefficent
18 months
Secondary Outcomes (6)
Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors
18 months
Correlation between serum level of endostatin and serum level of other angiogenic factors
18 months
Description of renal anomalies in Down syndrome.
18 months
Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects
18 months
Correlation between the number of optic nerve vessels and the presence of organs pathologies
18 months
- +1 more secondary outcomes
Study Arms (4)
Study group
OTHERDown Syndrome children
Control group n°1
OTHERDown Syndrome children's mothers
Control group n°2
OTHERAge and sex matched healthy children
Control group n°3
OTHERDown syndrome children's healthy siblings
Interventions
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
Measurements of each kidney will include maximum renal bipolar length in a sagittal plane, renal width and thickness in an axial plane perpendicular to each other at the level of renal hilum and cortical thickness. Intensity of corticomedullary differentiation will estimated. Doppler ultrasound examination will assess renal arterial resistivity indexes
Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.
weight, height and blood pressure will be assessed
Eligibility Criteria
You may qualify if:
- Provision of personally signed and dated informed consent document by adult subject or parents
- When capable of providing assent, provision of personally signed and dated informed assent document by children
- Subjects and/or their caregivers/parents are willing and able to comply with scheduled laboratory tests, and other required study procedures.
You may not qualify if:
- Inability to cooperate with study related examination
- For "Study Group" subjects
- Known chronic diseases unrelated to their triallelic condition For "Control Group n°1" \& "Control Group n°3"
- General disease in which the level of endostatin may be modified such as leukemia, cancers, inflammatory diseases (e.g.: rheumatoid arthritis, Crohn's disease, psoriasis)
- Any condition that may cause a hypoxia
- Pregnancy
- For "Control Group n°2":
- Healthy children except benign ophthalmological refraction anomalies
- Any known renal or low urinary tract diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lavina Postolache, MD
Queen Fabiola Children's University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2017
First Posted
July 2, 2017
Study Start
November 30, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
July 5, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share