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International Collaborative Gaucher Group (ICGG) Gaucher Registry
This study is currently recruiting participants.
Verified by Genzyme, October 2009
First Received: July 12, 2006   Last Updated: October 7, 2009   History of Changes
Sponsor: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00358943
  Purpose

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The objectives of the Registry are:

  • To enhance the understanding of the variability, progression, and natural history of Gaucher disease with the ultimate goal of better guiding and assessing therapeutic interventions;
  • To provide the Gaucher medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care; and
  • To evaluate the long-term effectiveness of enzyme replacement therapy (ERT).

Condition
Gaucher Disease
Cerebroside Lipidosis Syndrome
Glucocerebrosidase Deficiency Disease
Glucosylceramide Beta-Glucosidase Deficiency Disease

Study Type: Observational
Study Design: Prospective
Official Title: International Collaborative Gaucher Group (ICGG) Gaucher Registry

Resource links provided by NLM:


Further study details as provided by Genzyme:

Study Start Date: April 1991
Detailed Description:

The ICGG Gaucher Registry is an international program; in addition to the central contact information provided under the "Location" heading, patients may contact:

  • In Asia-Pacific - Margie Jimenez, +852 2810 1613
  • In Europe - +31-35-699-1232, europe@gaucherregistry.com
  • In Latin America - +617-591-5500, help@gaucherregistry.com
  • In North America - +617-591-5500, help@gaucherregistry.com
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gaucher disease

Criteria

Inclusion Criteria:

  • All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene.
  • For all patients, appropriate patient authorization will be obtained.

Exclusion Criteria:

  • No exclusion criteria for participation in the ICGG Gaucher Registry.NOTE: Registry participation does not exclude participation in other clinical studies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358943

Contacts
Contact: ICGG Gaucher Registry HelpLine 800-745-4447 ext x15500 help@gaucherregistry.com
Contact: ICGG Gaucher Registry HelpLine 617-591-5500 help@gaucherregistry.com

Locations
United States, Massachusetts
Registry participation is worldwide and not limited to this facility; facilities not yet active may enroll upon identification of a patient. Recruiting
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Genzyme Coporation ( Medical Monitor )
Study ID Numbers: ICGG Gaucher Registry
Study First Received: July 12, 2006
Last Updated: October 7, 2009
ClinicalTrials.gov Identifier: NCT00358943     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Genzyme:
Gaucher Disease
Glucocerebrosidase Deficiency Disease

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Sphingolipidoses
Disease
Metabolic Diseases
Reticuloendotheliosis
Lysosomal Storage Diseases, Nervous System
Lysosomal Storage Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Metabolism, Inborn Errors
Lymphatic Diseases
Pathologic Processes
Malnutrition
Genetic Diseases, Inborn
Syndrome
Nutrition Disorders
Lipidoses
Brain Diseases, Metabolic, Inborn
Gaucher Disease
Lipid Metabolism Disorders
Deficiency Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on February 08, 2010