International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
Gaucher Disease | Cerebroside Lipidosis Syndrome | Glucocerebrosidase Deficiency...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 understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
* To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
* To characterize the Gaucher disease population.
* To evaluate the long-term effectiveness of imiglucerase and of eliglustat.
Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
0 and up
Participation Criteria
Inclusion Criteria:
ICGG Gaucher Registry
* 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.
Gaucher Pregnancy Sub-registry:
* be enrolled in the ICGG Gaucher Registry.
* be pregnant, or have been pregnant with appropriate medical documentation available.
* provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.
Exclusion Criteria:
- No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry.
Study Location
Investigational Site Number : 124011
Investigational Site Number : 124011Vancouver, British Columbia
Canada
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Investigational Site Number : 124005
Investigational Site Number : 124005Kingston, Ontario
Canada
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Investigational Site Number : 124001
Investigational Site Number : 124001Sherbrooke, Quebec
Canada
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Investigational Site Number : 124010
Investigational Site Number : 124010Vancouver, British Columbia
Canada
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Investigational Site Number : 124024
Investigational Site Number : 124024Kingston, Ontario
Canada
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Investigational Site Number : 124013
Investigational Site Number : 124013Toronto, Ontario
Canada
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Investigational Site Number : 124014
Investigational Site Number : 124014Calgary, Alberta
Canada
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Investigational Site Number : 124019
Investigational Site Number : 124019Winnipeg, Manitoba
Canada
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Investigational Site Number : 124021
Investigational Site Number : 124021London, Ontario
Canada
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Investigational Site Number : 124002
Investigational Site Number : 124002Edmonton, Alberta
Canada
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Investigational Site Number : 124022
Investigational Site Number : 124022Moncton, New Brunswick
Canada
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Investigational Site Number : 124006
Investigational Site Number : 124006Toronto, Ontario
Canada
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- Study Sponsored By
- Sanofi
- Participants Required
- More Information
- Study ID:
NCT00358943