Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children

Down Syndrome Clinical Trial

— DOPANUR  

Official title:

Interventional Controlled Cross-sectional Study Assessing the Correlation Between Optic Nerve Vessels Anomalies, Serum Angiogenic Factors and Renal Anomalies in Children With Down Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206957
• Other study ID #: P2017/Ophtalmo/DOPANUR
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2018
• Source: Queen Fabiola Children's University Hospital
• Contact: Lavina Postolache, MD
• Phone: 0032 2 477 21 92
• Email: lavina.postolache[@]huderf.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Investigator will measure the serum levels of endostatin as well as others angiogenetic factors in Down syndrome children versus control group 1 constituted by the patient mothers.

Investigator will also perform renal and low urinary tract Doppler ultrasound with measurement of renal dimension in order to determine if the kidneys of patients with high level of serum of endostatin are smaller than those of patients with normal level of endostatin. Data observed in Down syndrome children will be compared to control group 2age constituted by sex and age matched healthy children Urine microalbuminuria and urine microalbuminuria/creatinuria from the first urine in the morning will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Down Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Funduscopic examination and retinal photography
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
• Serum levels of endostatin and angiogenesis factors
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
• Renal and low urinary tract Doppler ultrasound
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
Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.
• Anthropometric measures and vitals signs
weight, height and blood pressure will be assessed

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin	correlation coefficent	18 months
Secondary	Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors	correlation coefficent	18 months
Secondary	Correlation between serum level of endostatin and serum level of other angiogenic factors	correlation coefficient	18 months
Secondary	Description of renal anomalies in Down syndrome.	absolute number and type of renal anomalies	18 months
Secondary	Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects	Proportion and type of disease	18 months
Secondary	Correlation between the number of optic nerve vessels and the presence of organs pathologies	correlation coefficient	18 months
Secondary	Correlation between serum level of angiogenesis factors and the presence of organs pathologies	correlation coefficient	18 months