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

Primary Purpose

Down Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Funduscopic examination and retinal photography
Serum levels of endostatin and angiogenesis factors
Renal and low urinary tract Doppler ultrasound
Urinalysis
Anthropometric measures and vitals signs
Sponsored by
Queen Fabiola Children's University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Down Syndrome

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital Universitaire Des Enfants Reine FabiolaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Study group

Control group n°1

Control group n°2

Control group n°3

Arm Description

Down Syndrome children

Down Syndrome children's mothers

Age and sex matched healthy children

Down syndrome children's healthy siblings

Outcomes

Primary Outcome Measures

Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
correlation coefficent

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2017
Last Updated
July 3, 2018
Sponsor
Queen Fabiola Children's University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03206957
Brief Title
Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Fabiola Children's University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional controlled cross-sectional study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Other
Arm Description
Down Syndrome children
Arm Title
Control group n°1
Arm Type
Other
Arm Description
Down Syndrome children's mothers
Arm Title
Control group n°2
Arm Type
Other
Arm Description
Age and sex matched healthy children
Arm Title
Control group n°3
Arm Type
Other
Arm Description
Down syndrome children's healthy siblings
Intervention Type
Diagnostic Test
Intervention Name(s)
Funduscopic examination and retinal photography
Intervention Description
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum levels of endostatin and angiogenesis factors
Intervention Description
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
Intervention Type
Diagnostic Test
Intervention Name(s)
Renal and low urinary tract Doppler ultrasound
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinalysis
Intervention Description
Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.
Intervention Type
Diagnostic Test
Intervention Name(s)
Anthropometric measures and vitals signs
Intervention Description
weight, height and blood pressure will be assessed
Primary Outcome Measure Information:
Title
Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
Description
correlation coefficent
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors
Description
correlation coefficent
Time Frame
18 months
Title
Correlation between serum level of endostatin and serum level of other angiogenic factors
Description
correlation coefficient
Time Frame
18 months
Title
Description of renal anomalies in Down syndrome.
Description
absolute number and type of renal anomalies
Time Frame
18 months
Title
Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects
Description
Proportion and type of disease
Time Frame
18 months
Title
Correlation between the number of optic nerve vessels and the presence of organs pathologies
Description
correlation coefficient
Time Frame
18 months
Title
Correlation between serum level of angiogenesis factors and the presence of organs pathologies
Description
correlation coefficient
Time Frame
18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lavina Postolache, MD
Phone
0032 2 477 21 92
Email
lavina.postolache@huderf.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavina Postolache, MD
Organizational Affiliation
Queen Fabiola Children's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Universitaire Des Enfants Reine Fabiola
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavina Postolache, MD
Phone
0032 2 477 21 92
Email
lavina.postolache@huderf.be
First Name & Middle Initial & Last Name & Degree
Lavina Postolache, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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