Down SyndromeDOPANURNCT03206957
Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children
A study testing Funduscopic examination and retinal photography, Serum levels of endostatin and angiogenesis factors and Renal and low urinary tract Doppler ultrasound in people with Down Syndrome, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Funduscopic examination and retinal photography, Serum levels of endostatin and angiogenesis factors and Renal and low urinary tract Doppler ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Nov 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- For "Control Group n°2":
- Healthy children except benign ophthalmological refraction anomalies
- Any known renal or low urinary tract diseases.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Lavina Postolache, MD, 0032 2 477 21 92, lavina.postolache@huderf.be
Lavina Postolache, MD
About this study
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.
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- 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
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Funduscopic examination and retinal photographyDiagnostic test
A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
Serum levels of endostatin and angiogenesis factorsDiagnostic test
Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
Renal and low urinary tract Doppler ultrasoundDiagnostic test
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
UrinalysisDiagnostic test
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 signsDiagnostic test
weight, height and blood pressure will be assessed
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Down Syndrome children Receives: 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 |
| Control group n°1 | Other | Down Syndrome children's mothers Receives: Diagnostic Test: Funduscopic examination and retinal photography; Diagnostic Test: Serum levels of endostatin and angiogenesis factors |
| Control group n°2 | Other | Age and sex matched healthy children Receives: Diagnostic Test: Funduscopic examination and retinal photography; Diagnostic Test: Renal and low urinary tract Doppler ultrasound; Diagnostic Test: Urinalysis; Diagnostic Test: Anthropometric measures and vitals signs |
| Control group n°3 | Other | Down syndrome children's healthy siblings Receives: Diagnostic Test: Funduscopic examination and retinal photography; Diagnostic Test: Serum levels of endostatin and angiogenesis factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
correlation coefficent
Measured: 18 months
Secondary outcomes (6)
Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors
correlation coefficent
Measured: 18 months
Correlation between serum level of endostatin and serum level of other angiogenic factors
correlation coefficient
Measured: 18 months
Description of renal anomalies in Down syndrome.
absolute number and type of renal anomalies
Measured: 18 months
Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects
Proportion and type of disease
Measured: 18 months
Correlation between the number of optic nerve vessels and the presence of organs pathologies
correlation coefficient
Measured: 18 months
Correlation between serum level of angiogenesis factors and the presence of organs pathologies
correlation coefficient
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start30 Nov 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional controlled cross-sectional study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lavina Postolache, MD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206957
- Sponsor's protocol ID
- P2017/Ophtalmo/DOPANUR
- Acronym
- DOPANUR
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03206957
- Acronym / sponsor ID
- DOPANUR / P2017/Ophtalmo/DOPANUR
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Interventional controlled cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | 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 signsDown Syndrome children |
| Control group n°1 | Other | Diagnostic Test: Funduscopic examination and retinal photography, Diagnostic Test: Serum levels of endostatin and angiogenesis factorsDown Syndrome children's mothers |
| Control group n°2 | Other | Diagnostic Test: Funduscopic examination and retinal photography, Diagnostic Test: Renal and low urinary tract Doppler ultrasound, Diagnostic Test: Urinalysis, Diagnostic Test: Anthropometric measures and vitals signsAge and sex matched healthy children |
| Control group n°3 | Other | Diagnostic Test: Funduscopic examination and retinal photography, Diagnostic Test: Serum levels of endostatin and angiogenesis factorsDown syndrome children's healthy siblings |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Funduscopic examination and retinal photographyA standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve. | Diagnostic test | Control group n°1, Control group n°2, Control group n°3, Study group |
| Serum levels of endostatin and angiogenesis factorsSerum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed | Diagnostic test | Control group n°1, Control group n°3, Study group |
| Renal and low urinary tract Doppler ultrasoundMeasurements 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 | Control group n°2, Study group |
| UrinalysisUrinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void. | Diagnostic test | Control group n°2, Study group |
| Anthropometric measures and vitals signsweight, height and blood pressure will be assessed | Diagnostic test | Control group n°2, Study group |
Primary outcome
Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
Time frame: 18 months
correlation coefficent
6 secondary outcomes
Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors
Time frame: 18 months
Correlation between serum level of endostatin and serum level of other angiogenic factors
Time frame: 18 months
Description of renal anomalies in Down syndrome.
Time frame: 18 months
Comparison of prevalence of renal anomalies between Down syndrome and healthy subjects
Time frame: 18 months
Correlation between the number of optic nerve vessels and the presence of organs pathologies
Time frame: 18 months
Correlation between serum level of angiogenesis factors and the presence of organs pathologies
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavina Postolache, MD principal investigator
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Funduscopic examination and retinal photography, Serum levels of endostatin and angiogenesis factors and Renal and low urinary tract Doppler ultrasound in people with Down Syndrome, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lavina Postolache, MD (0032 2 477 21 92, lavina.postolache@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.