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

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ClinicalTrials.gov Identifier: NCT03206957
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Diagnostic Test: Funduscopic examination and retinal photography Diagnostic Test: Serum levels of endostatin and angiogenesis factors Diagnostic Test: Renal and low urinary tract Doppler ultrasound Diagnostic Test: Urinalysis Diagnostic Test: Anthropometric measures and vitals signs Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional controlled cross-sectional study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019


Arm Intervention/treatment
Study group
Down Syndrome children
Diagnostic Test: Funduscopic examination and retinal photography
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.

Diagnostic Test: Serum levels of endostatin and angiogenesis factors
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed

Diagnostic Test: 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


Diagnostic Test: Urinalysis
Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.

Diagnostic Test: Anthropometric measures and vitals signs
weight, height and blood pressure will be assessed

Control group n°1
Down Syndrome children's mothers
Diagnostic Test: Funduscopic examination and retinal photography
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.

Diagnostic Test: Serum levels of endostatin and angiogenesis factors
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed

Control group n°2
Age and sex matched healthy children
Diagnostic Test: Funduscopic examination and retinal photography
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.

Diagnostic Test: 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


Diagnostic Test: Urinalysis
Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.

Diagnostic Test: Anthropometric measures and vitals signs
weight, height and blood pressure will be assessed

Control group n°3
Down syndrome children's healthy siblings
Diagnostic Test: Funduscopic examination and retinal photography
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.

Diagnostic Test: Serum levels of endostatin and angiogenesis factors
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed




Primary Outcome Measures :
  1. Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin [ Time Frame: 18 months ]
    correlation coefficent


Secondary Outcome Measures :
  1. Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors [ Time Frame: 18 months ]
    correlation coefficent

  2. Correlation between serum level of endostatin and serum level of other angiogenic factors [ Time Frame: 18 months ]
    correlation coefficient

  3. Description of renal anomalies in Down syndrome. [ Time Frame: 18 months ]
    absolute number and type of renal anomalies

  4. Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects [ Time Frame: 18 months ]
    Proportion and type of disease

  5. Correlation between the number of optic nerve vessels and the presence of organs pathologies [ Time Frame: 18 months ]
    correlation coefficient

  6. Correlation between serum level of angiogenesis factors and the presence of organs pathologies [ Time Frame: 18 months ]
    correlation coefficient



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03206957


Contacts
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Contact: Lavina Postolache, MD 0032 2 477 21 92 lavina.postolache@huderf.be

Locations
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Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Lavina Postolache, MD    0032 2 477 21 92    lavina.postolache@huderf.be   
Principal Investigator: Lavina Postolache, MD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
Investigators
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Principal Investigator: Lavina Postolache, MD Queen Fabiola Children's University Hospital

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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT03206957     History of Changes
Other Study ID Numbers: P2017/Ophtalmo/DOPANUR
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Congenital Abnormalities
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn
Endostatins
Angiogenesis Inducing Agents
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors