Sickle Cell DiseaseNCT04205123
Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome. The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- sickle cell syndrome
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2014to 1 Jan 2025
- Phase
- Observational
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will characterize the population of sickle cell patients 17 years and older , followed by Belgium and the Nord-Pas -De- Calais, and in the study through the signing of an inform consent.
Who may be able to join
- Patients 18 years or older with sickle cell syndrome
- Signing an inform consent form after validation on it by the Ethics Committees of the participating centers.
Who cannot join
- Any pathology concomitant risk of nephropathy
- Severe CVO within the month preceding the sampling
- Transfusions within 3 months prior to sampling
- Pregnant patient or within 3 months post- accouhcement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Academic Multicenter Prospective Observational Study of the Factors Responsible for Nephropathy in Patients With Sickle Cell Disease Followed by Belgium and the Nord-Pas -De- Calais Region and Creating a Biobank of Blood and Urine
The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome.
The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.
Read the detailed description
Some additional tubes will be taken during the usual control of blood test of the drepanocytic patient. A sample of urine will be also asked. Tubes, after pre-treatment, will be sent to Erasme hospital.
A series ob biological but also genetic parameters, both at asymptomatic patients and those in aigüe phase of the disease, can be measured either immediately or a little time after the prelevement.
In this way, we can study numerous domains linked to the physiopathology of the drepanocytose (hémolyse, vaso-occlusion, rheology, factors modulators of the clinical expression). The surplus of the collection could be used for other researchs. It's in this context that we also wish to constitute a biobank of serum, plasma and urine for these drepanocytic patients by surplus of taken material.
The study is realized within the framework of an academic collaboration between institutions. The bank of takings will be located in the reference center of the pathologies of the Red Blood Cell (laboratory of medical chemistry of the erasme hospital).
- Conditions
- Sickle Cell Disease
- Being tested
- sickle cell syndrome
- Keywords
- sickle cell disease, nephropathy
- Medical subject headings
- Anemia, Sickle Cell, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sickle cell syndromeGenetic
Academic Study prospective multicenter observational factors responsible for nephropathy in patients with sickle cell disease followed by Belgium and the Nord-Pas -De- Calais Region and creating a biobank of blood and urine.
In the population of patients with SCD followed in all participating centres.
Know the prevalence of nephropathy and the relationship between it with their some of their genotypic mutations and clinical phenotype promoting mutated hemoglobin polymerization.
Determine the behaviour of dense cells in the basal state and in a hypeosmolaire environment
Determine the place of the erythrocyte microparticles as a biomarker of sickle cell nephropathy
Studying genes known as risk factor for proteinuria
Create a BioBank of samples of sickle cell patients in clinically stable condition for other research purposes.
| Study group | Role | What they receive |
|---|---|---|
| sickle cell syndrome | Inclusions of sickle cell patients aged over 17 years followed regularly in the participating centers. Receives: Genetic: sickle cell syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Albumin
Nephropathy Prevalence
Measured: each year
Secondary outcomes (3)
Erythrocyte Microparticles
Sickle cell Nephropathy biomarker
Measured: each year
Eythrocyte Deformability and Erythrocyte Agregation
Sickle Cell Nephropathy Biomarker
Measured: each year
Hp, ApoL1 and HO-1 gene
Sickle Cell Nephropathy risk factor
Measured: first year of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start20 Oct 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205123
- Sponsor's protocol ID
- P2014/251
- Status last verified
- Dec 2019
- First submitted
- 8 Oct 2014
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic Multicenter Prospective Observational Study of the Factors Responsible for Nephropathy in Patients With Sickle Cell Disease Followed by Belgium and the Nord-Pas -De- Calais Region and Creating a Biobank of Blood and Urine
- ClinicalTrials.gov ID
- NCT04205123
- Acronym / sponsor ID
- P2014/251
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2014
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Dec 2019 (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.
The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome.
The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.
Detailed description
Some additional tubes will be taken during the usual control of blood test of the drepanocytic patient. A sample of urine will be also asked. Tubes, after pre-treatment, will be sent to Erasme hospital.
A series ob biological but also genetic parameters, both at asymptomatic patients and those in aigüe phase of the disease, can be measured either immediately or a little time after the prelevement.
In this way, we can study numerous domains linked to the physiopathology of the drepanocytose (hémolyse, vaso-occlusion, rheology, factors modulators of the clinical expression). The surplus of the collection could be used for other researchs. It's in this context that we also wish to constitute a biobank of serum, plasma and urine for these drepanocytic patients by surplus of taken material.
The study is realized within the framework of an academic collaboration between institutions. The bank of takings will be located in the reference center of the pathologies of the Red Blood Cell (laboratory of medical chemistry of the erasme hospital).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sickle cell syndrome | – | Genetic: sickle cell syndromeInclusions of sickle cell patients aged over 17 years followed regularly in the participating centers. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will characterize the population of sickle cell patients 17 years and older , followed by Belgium and the Nord-Pas -De- Calais, and in the study through the signing of an inform consent.
Key inclusion criteria (2 listed)
- Patients 18 years or older with sickle cell syndrome
- Signing an inform consent form after validation on it by the Ethics Committees of the participating centers.
Key exclusion criteria (4 listed)
- Any pathology concomitant risk of nephropathy
- Severe CVO within the month preceding the sampling
- Transfusions within 3 months prior to sampling
- Pregnant patient or within 3 months post- accouhcement
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 |
|---|---|---|
| sickle cell syndromeAcademic Study prospective multicenter observational factors responsible for nephropathy in patients with sickle cell disease followed by Belgium and the Nord-Pas -De- Calais Region and creating a biobank of blood and urine. In the population of patients with SCD followed in all participating centres. Know the prevalence of nephropathy and the relationship between it with their some of their genotypic mutations and clinical phenotype promoting mutated hemoglobin polymerization. Determine the behaviour of dense cells in the basal state and in a hypeosmolaire environment Determine the place of the erythrocyte microparticles as a biomarker of sickle cell nephropathy Studying genes known as risk factor for proteinuria Create a BioBank of samples of sickle cell patients in clinically stable condition for other research purposes. | Genetic | sickle cell syndrome |
Primary outcome
Urinary Albumin
Time frame: each year
Nephropathy Prevalence
3 secondary outcomes
Erythrocyte Microparticles
Time frame: each year
Eythrocyte Deformability and Erythrocyte Agregation
Time frame: each year
Hp, ApoL1 and HO-1 gene
Time frame: first year of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Erasme 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 2 inclusion and 4 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 19 Dec 2019. 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 Béatrice BG Gulbis, Phd MD (+32 02 555 34 27 ext. 3427, Chimie@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Albumin (time frame: each year). 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 19 Dec 2019.