An observational study in Sickle Cell Anemia and Sickle Cell Disease, sponsored by Cardiologie et Développement. Status unknown at 13 sites in 6 countries. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-25.
Sponsored by Cardiologie et Développement · Observational
The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.
Sickle cell disease (SCD), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. Most patients with this disease are homozygous for the βS allele (SS), whereas others have inherited a βS allele with another mutation in the β globin gene. In addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers.
CADRE is a multinational prospective observational study undertaken in five countries in sub-Saharan Africa. Patients with SCD will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. The CADRE protocol was approved by the relevant national ethics committee in each of the participating countries.
Primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of SCD: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers.
Secondary endpoints are:
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 100 across 296 observational studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Cardiologie et Développement is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adult patients with the sickle cell disease living in subSaharan Africa
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
unstable clinical status such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* age: five-year-old or more * major sickle cell syndrome confirmed by hemoglobin phenotype: SS, SC, SBeta+ or Sbeta0 * steady state defined as the absence of vaso-occlusive crisis for the previous 15 days, absence of fever or infectious disease for the previous 8 days and absence of transfusion for the previous 2 months
* volunteer parents or siblings of sickle cell patients * hospital staff or their children matched on country and age +/- 3 ans with the patients
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy
urinary albumin/creatinin ratio (mg/g)
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy
left ventricular ejection fraction \< 60 %
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension
tricuspid regurgitation jet velocity (m/s)
Time frame: 10 years
Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy
retinal examination
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke
clinical diagnosis
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis
standard radiography
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers
clinical diagnosis
Time frame: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism
clinical diagnosis
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity
measured by Pulsepen, m/s)
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: complete blood count
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: LDH level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: bilirubin level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: microparticules measure
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: free heme level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps
Time frame: 10 years
Plan to share: No
Started Mar 2012 (actual). Primary completion is estimated for Dec 2020, 105 months after the start.
Of 130 non-industry observational studies under Anemia, Sickle Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 109. This study's planned 105 months is above that.
Counting every sponsor, half of 139 studies reached it within 49 months; a quarter within 24 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Cardiologie et Développement