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Sickle-cell Disease Registry of the GPOH (SichReg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327428
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : November 9, 2022
Sponsor:
Collaborators:
GPOH Consortium Sickle Cell Disease
Johann Wolfgang Goethe University Hospital
Universitätsklinikum Hamburg-Eppendorf
University Hospital Ulm
Charite University, Berlin, Germany
Deutsche Kinderkrebsstiftung
Information provided by (Responsible Party):
Dr. Joachim Kunz, University Hospital Heidelberg

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with Sickle Cell Disease
Patients with any sickling condition, including among others Sickle Cell Anemia, HbSC Disease, HbS-betaThal, excluding Sickle Cell Trait.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
All patients with sickle cell disease being treated at participating centers that signed the informed consent form.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- isolated heterozygous trait for HbS

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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Germany
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   
Sponsors and Collaborators
University Hospital Heidelberg
GPOH Consortium Sickle Cell Disease
Johann Wolfgang Goethe University Hospital
Universitätsklinikum Hamburg-Eppendorf
University Hospital Ulm
Charite University, Berlin, Germany
Deutsche Kinderkrebsstiftung
Investigators
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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
More Information
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Additional Information:

Publications of Results:

Other Publications:
Lobitz S. Neugeborenenscreening auf Sichelzellkrankheiten in Deutschland. Kinder- und Jugendmedizin 2017;17(2):82-86 [German]

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Responsible Party: Dr. Joachim Kunz, Senior physician, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03327428    
Other Study ID Numbers: Register Sichelzellkrankheit
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Joachim Kunz, University Hospital Heidelberg:
Anemia, Sickle Cell
Sickle Cell disease
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn