- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05564845
Brain Structure and Neurocognitive Development in Sickle Cell Disease; a Longitudinal Cohort Study (BRICK Study) (BRICK)
Study Overview
Status
Conditions
Detailed Description
Objective: The primary objective is to evaluate longitudinal developmental changes in brain structure in patients aged 6-18 years with SCD. The secondary objective is to analyze the longitudinal relations between biomarkers, demographic characteristics, brain structure, neurocognitive functioning, behavioral functioning and developmental changes in brain structure.
Study Design: Longitudinal cohort study (BRICK) with a duration of 4 years. Study population: Children and adolescents with sickle cell disease (SCD) of all genotypes (e.g. HbSS, HbSβº, HbSβ+, and HbSC) aged 6 -18 years. This will be compared to a cohort of healthy children and adolescents from Generation R.
Primary study endpoint:
- Total white matter volume increase in children and adolescents with SCD Secondary study endpoints
- Neurocognitive functioning (intelligence, specific neurocognitive functions, network organization)
- Incidence of stroke
- Other forms complications due to SCD
- Amount of hospital admissions, day care admissions (adult care only), crises at home, contact moments with the sickle cell center, ER visits
- Biomarkers for anemia, hemolysis, inflammation and endothelial activation.
- Behavioral functioning Nature and extent of the burden and risk associated with participation, benefit and group relatedness: By creating an advanced model for structural neurological, neurocognitive functioning in SCD, we will gain more insight into the pathophysiological origins and risk factors for SCD-related brain abnormalities. This will support development of preventive and supportive strategies as well as the initiation and evaluation of therapeutic interventions. Previous experience with the performance of brain MRI scans combined with recent research, indicates that the emotional burden placed on young children when undergoing a brain MR scan, are proportionate to the emotional burden placed on adults when they undergo a brain MR-scan. Furthermore, children will be offered the opportunity to become acquainted with the research procedure by witnessing an MRI scan session prior before participation.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Aida Kidane
- Phone Number: +3110-7036691
- Email: a.kidanegebremeskel@erasmusmc.nl
Study Contact Backup
- Name: Marjon Cnossen
- Phone Number: +310-7036691
- Email: m.cnossen@erasmusmc.nl
Study Locations
-
-
-
Amsterdam, Netherlands
- Not yet recruiting
- Amsterdam University Medical Center
-
Contact:
- Noa IJdo
- Email: n.ijdo@amsterdamumc.nl
-
Principal Investigator:
- Karin Fijnvandraat, MD, PhD
-
Sub-Investigator:
- Noa IJdo, MsC
-
-
South Holland
-
Rotterdam, South Holland, Netherlands, 3000 CA
- Recruiting
- Erasmus MC
-
Contact:
- Aida Kidane
- Email: a.kidanegebremeskel@erasmusmc.nl
-
Principal Investigator:
- Marjon Cnossen, MD, PhD
-
Sub-Investigator:
- Aida Kidane, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Children and adolescents diagnosed with SCD of all genotypes, treated at Erasmus MC and the Amsterdam UMC, ranging from 6 to 18 years at initiation of the study.
The clinical phenotype of SCD consists of a spectrum: From the patients with a high hemoglobin plus an absent or lower incidence of VOCs to the patients with a higher hemoglobin and a higher incidence of VOCs. We chose to include SCD patients of all genotypes, not only the HbSS and Hbẞ0 thalassemia, to cover the whole phenotypic range of SCD. This was chosen in order to infer the possible causes of an expected difference in white matter volume increase, like anemia and sickling-propensity.
Description
Inclusion Criteria:
- Patients with SCD of all genotype between 6 and 18 at baseline
Exclusion Criteria:
Parents/ guardians (in case of minors) or patients themselves (>16 years) unable to make an informed decision on participating in this study.
- An abnormal brain MRI prior to initiation of the study due to non-SCD related causes.
- Contraindications for brain MRI per protocol
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe SCD genotypes
Children between 6 and 18 years of age of genotypes HbSS, HbSβº
|
Subjects will undergo MRI of the head, blood sampling and neurological examination on the same day or spread over 2 days.
On a separate day from blood sampling and undergoing an MRI scan, the neuropsychological assessment will take place.
The interval between the MRI scan and the neuropsychological assessment will be a maximum of 2 months.
These measurements will be performed a total of 3 times with an interval of 2 years.
Lab work for current lab values and biobanking
Classical neurological examination
Overview of standard neurocognitive assessment tools in BRICK study Children and adolescents (Young) Adults
Emma toolbox |
Not severe SCD genotypes
Children between 6 and 18 years of age of genotypes HbSβ+, and HbSC and more
|
Subjects will undergo MRI of the head, blood sampling and neurological examination on the same day or spread over 2 days.
On a separate day from blood sampling and undergoing an MRI scan, the neuropsychological assessment will take place.
The interval between the MRI scan and the neuropsychological assessment will be a maximum of 2 months.
These measurements will be performed a total of 3 times with an interval of 2 years.
Lab work for current lab values and biobanking
Classical neurological examination
Overview of standard neurocognitive assessment tools in BRICK study Children and adolescents (Young) Adults
Emma toolbox |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mm3/time unit
Time Frame: 4 years
|
Total white matter volume increase in children and adolescents with SCD
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Full scale IQ (FSIQ)
Time Frame: 4 years
|
Neurocognitive functioning (intelligence, specific neurocognitive functions, network organization)
|
4 years
|
Incidence of stroke
Time Frame: 4 years
|
4 years
|
|
Other forms complications due to SCD
Time Frame: 4 years
|
4 years
|
|
Amount of hospital admissions
Time Frame: 4 years
|
4 years
|
|
Ld, bilirubin
Time Frame: 4 years
|
Hemolysis biomarkers
|
4 years
|
Times/year
Time Frame: 4 years
|
ER visits
|
4 years
|
Hb, Ht
Time Frame: 4 years
|
Biomarkers for anemia
|
4 years
|
T score metric: a score of 50 represents the mean score of a reference population and 10 is the standard deviation.
Time Frame: 4 years
|
Patient-Reported Outcomes Measurement Information System® (PROMIS) within domains such as fatigue, pain behavior, depression, anxiety
|
4 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC-25022-0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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