Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease
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| ClinicalTrials.gov Identifier: NCT04205123 |
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Recruitment Status :
Recruiting
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
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| Tracking Information | |||||||||
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| First Submitted Date | October 8, 2014 | ||||||||
| First Posted Date | December 19, 2019 | ||||||||
| Last Update Posted Date | December 19, 2019 | ||||||||
| Study Start Date | October 20, 2014 | ||||||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Urinary Albumin [ Time Frame: each year ] Nephropathy Prevalence
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Urine, Plasma and Serum aliquotes in a biobank [ Time Frame: Each year ] For additional projects
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease | ||||||||
| 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 | ||||||||
| Brief 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 prevent the installation of some complications or to limit their worsening. |
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| 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). |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood and Urine Samples
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| Sampling Method | Non-Probability Sample | ||||||||
| 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. | ||||||||
| Condition | Sickle Cell Disease | ||||||||
| Intervention | Genetic: sickle cell syndrome
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. |
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| Study Groups/Cohorts | sickle cell syndrome
Inclusions of sickle cell patients aged over 17 years followed regularly in the participating centers.
Intervention: Genetic: sickle cell syndrome
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 1, 2025 | ||||||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 17 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04205123 | ||||||||
| Other Study ID Numbers | P2014/251 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Erasme University Hospital | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Erasme University Hospital | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Erasme University Hospital | ||||||||
| Verification Date | December 2019 | ||||||||