Sickle-cell Disease Registry of the GPOH (SichReg)
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|ClinicalTrials.gov Identifier: NCT03327428|
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : November 9, 2022
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Sickle cell disease is one of the most common hereditary diseases. Most severe complications can be avoided if the disease is detected early and treated appropriately.
The sickle cell disease registry of the Society for Paediatric Oncology/Haematology aims at describing the epidemiology of sickle cell disease in German-speaking central Europe. Patients with sickle cell disease will be characterized clinically and genetically and treatment will be documented with the aim to find predictors of the course of disease.
In addition, the registry results should provide a solid evidence base to incorporate sickle cell disease into routine newborn screening and to update the national guidelines for the management of patients suffering from sickle cell disease in Germany.
A consortium of five university hospitals (Berlin, Frankfurt, Hamburg, Heidelberg, Ulm) has been mandated by the Society for Paediatric Oncology/Haematology to implement this registry.
The number of participating centers is constantly increasing and new centers that take care of either pediatric or adult patients with sickle cell disease are encouraged to support the registry.
For further information please refer to: http://www.sichelzellkrankheit.info/
|Condition or disease|
|Sickle Cell Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Register Sichelzellkrankheit Der GPOH|
|Actual Study Start Date :||December 15, 2016|
|Estimated Primary Completion Date :||December 31, 2026|
|Estimated Study Completion Date :||December 31, 2040|
Patients with Sickle Cell Disease
Patients with any sickling condition, including among others Sickle Cell Anemia, HbSC Disease, HbS-betaThal, excluding Sickle Cell Trait.
- Change in incidence of sickle-cell disease [ Time Frame: Baseline and yearly, up to 10 years ]The incidence of sickle-cell disease will be reported every year in comparison to the preceding Report.
- Complications of sickle-cell disease [ Time Frame: Baseline and yearly, up to 10 years ]In addition to the incidence of the disease itself also possible complications will be reported in comparison to the preceding report (in case of the first report, only the prevalence will be reported as baseline).
- Treatment of sickle-cell disease [ Time Frame: Baseline and yearly, up to 10 years ]In addition to the incidence of the disease itself also the treatment received will be reported in comparison to the preceding report (in case of the first report, only the prevalence will be reported as baseline).
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|Ages Eligible for Study:||0 Years to 100 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- signed informed consent
- current residency in either Germany, Austria or Switzerland
sickle cell disease confirmed by hemoglobin analysis or molecular genetic analysis
- Homozygous sickle cell disease (HbSS)
- HbSC disease
- Sickle cell disease HbS / bThal
- Other, rare sickle cell syndromes such as HbS/OArab, HbS/HPFH, HbS/E, HbS/D Punjab, HbS/C Harlem, HbC/S Antilles, HbS/Quebec-CHORI, HbA/S Oman, HbA/Jamaica Plain
- isolated heterozygous trait for HbS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327428
|Contact: Joachim Kunz, Dr.||06221 56 4555||Joachim.Kunz@med.uni-heidelberg.de|
|Contact: Laura Tagliaferri, Dr.||06221 56 4555||Laura.Tagliaferri@med.uni-heidelberg.de|
|Center for Child and Adolescent Medicine, University Medical Center Heidelberg||Recruiting|
|Heidelberg, BW, Germany, 69124|
|Contact: Joachim Kunz, Dr. 06221 56 4555 Joachim.Kunz@med.uni-heidelberg.de|
|Contact: Laura Tagliaferri, Dr. 06221 56 4555 Laura.Tagliaferri@med.uni-heidelberg.de|
|Principal Investigator:||Joachim Kunz, Dr.||Center for Child and Adolescent Medicine, University Medical Center Heidelberg|
|OverallOfficial:||Holger Cario, Prof. Dr.||University Hospital Ulm|
|OverallOfficial:||Regine Grosse, Dr.||Universitätsklinikum Hamburg-Eppendorf|
|OverallOfficial:||Andrea Jarisch, Dr.||Johann Wolfgang Goethe University Hospital|
|OverallOfficial:||Andreas Kulozik, Prof. Dr.||University Hospital Heidelberg|
|OverallOfficial:||Stephan Lobitz, Dr. MSc||Gemeinschaftsklinikum Mittelrhein, Koblenz|
|OverallOfficial:||Lena Oevermann||Charite University, Berlin, Germany|
Publications of Results:
|Responsible Party:||Dr. Joachim Kunz, Senior physician, University Hospital Heidelberg|
|Other Study ID Numbers:||
|First Posted:||October 31, 2017 Key Record Dates|
|Last Update Posted:||November 9, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Sickle Cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn