Sickle-cell Disease Registry of the GPOH (SichReg)

November 30, 2023 updated by: Dr. Joachim Kunz, University Hospital Heidelberg

Register Sichelzellkrankheit Der GPOH

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/

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and yearly, up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and yearly, up to 10 years
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).
Baseline and yearly, up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Charite University, Berlin, Germany
Pfizer
German Cancer Research Center
Johann Wolfgang Goethe University Hospital
Universitätsklinikum Hamburg-Eppendorf
Deutsche Kinderkrebsstiftung
University Hospital Ulm
GPOH Consortium Sickle Cell Disease

Investigators

  • Principal Investigator: Joachim Kunz, Dr., Center for Child and Adolescent Medicine, University Medical Center Heidelberg
  • Holger Cario, Prof. Dr., University Hospital Ulm
  • Andrea Jarisch, Dr., Johann Wolfgang Goethe University Hospital
  • Andreas Kulozik, Prof. Dr., University Hospital Heidelberg
  • Stephan Lobitz, Dr. MSc, Gemeinschaftsklinikum Mittelrhein, Koblenz
  • Lena Oevermann, Charite University, Berlin, Germany
  • Regine Grosse, Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Register Sichelzellkrankheit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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