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International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
NCT00358943 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (20)
California
- Tower Hematology/Oncology Medical Group- Site Number : 840056 — Beverly Hills
- University of California at Irvine- Site Number : 840036 — Irvine
- Southern California Permanente Medical Group- Site Number : 840108 — Los Angeles
- USC Health Sciences Center Dept of Genetics- Site Number : 840082 — Los Angeles
- Children's Hospital of Orange County- Site Number : 840074 — Orange
- Stanford Unviersity MC Dept of Genetics- Site Number : 840022 — Palo Alto
- UC Davis MIND Institute- Site Number : 840010 — Sacramento
- Kaiser Permanente Hospital- Site Number : 840042 — Sacramento
- University of California at San Diego- Site Number : 840007 — San Diego
- University of California at San Francisco- Site Number : 840051 — San Francisco
Florida
- University Hematology Oncology- Site Number : 840075 — Coral Springs
- University of Florida Pediatrics Genetics- Site Number : 840121 — Jacksonville
- The Atwal Clinic- Site Number : 840112 — Jacksonville
- University Of Miami SOM- Site Number : 840006 — Miami
Arizona
- Phoenix Children's Hospital- Site Number : 840003 — Phoenix
- University of Arizona- Site Number : 840015 — Tucson
Arkansas
- Arkansas Childrens Hospital- Site Number : 840109 — Little Rock
- University of Arkansas for Medical Sciences- Site Number : 840113 — Little Rock
Connecticut
- Yale - Site Number : 840047 — New Haven
District of Columbia
- Children's National Medical Center- Site Number : 840067 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,000 participants |
| Start Date | 1991-04-01 |
| Est. Completion | 2034-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358943
The ClinicalTrials.gov registry entry for NCT00358943 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Gaucher Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00358943 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00358943 about?
NCT00358943 is a clinical study titled "International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry". 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 asses...
What is the current status of trial NCT00358943?
This trial is currently recruiting. The enrollment target is 12,000 participants. The study started on 1991-04-01. Estimated completion is 2034-01-31.
What conditions does trial NCT00358943 study?
This clinical trial studies the following conditions: Gaucher Disease, Cerebroside Lipidosis Syndrome, Glucocerebrosidase Deficiency Disease, Glucosylceramide Beta-Glucosidase Deficiency Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00358943?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00358943 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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