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SichReg: Sickle-cell Disease Registry of the GPOH

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Recruiting
CT.gov ID
NCT03327428
Collaborator
GPOH Consortium Sickle Cell Disease (Other), Johann Wolfgang Goethe University Hospital (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University Hospital Ulm (Other), Charite University, Berlin, Germany (Other), Deutsche Kinderkrebsstiftung (Other)
500
Enrollment
1
Location
288.5
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Register Sichelzellkrankheit Der GPOH
    Actual Study Start Date :
    Dec 15, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2040

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Change in incidence of sickle-cell disease [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 [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 [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

    Criteria

    Ages Eligible for Study:
    0 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Center for Child and Adolescent Medicine, University Medical Center Heidelberg Heidelberg BW Germany 69124

    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

    • Principal Investigator: Joachim Kunz, Dr., Center for Child and Adolescent Medicine, University Medical Center Heidelberg
    • : Holger Cario, Prof. Dr., University Hospital Ulm
    • : Regine Grosse, Dr., Universitätsklinikum Hamburg-Eppendorf
    • : Andrea Jarisch, Dr., Johann Wolfgang Goethe University Hospital
    • : Andreas Kulozik, Prof. Dr., University Hospital Heidelberg
    • : Stephan Lobitz, Dr. MSc, Kiniken der Stadt Köln gGmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dr. Joachim Kunz, Senior physician, University Hospital Heidelberg
    ClinicalTrials.gov Identifier:
    NCT03327428
    Other Study ID Numbers:
    • Register Sichelzellkrankheit
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Joachim Kunz, Senior physician, University Hospital Heidelberg
    Anemia, Sickle Cell
    Sickle Cell disease
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Jan 11, 2021