International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

Recruiting now

Conditions studied: Gaucher Disease, Cerebroside Lipidosis Syndrome, Glucocerebrosidase Deficiency Disease, Glucosylceramide Beta-Glucosidase Deficiency Disease

In brief

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.

Key facts

Study ID

NCT00358943

Run by

Genzyme, a Sanofi Company

People needed

12000

Starts

1991-04-01

Expected to finish

2034-01-31

Last updated by the study team

2026-04-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry.

Where it is running

• Rush University Medical Center Genetics- Site Number : 840079 — Chicago, Illinois, United States (enrolling)
• Indianapolis University School of Medicine- Site Number : 840027 — Indianapolis, Indiana, United States (enrolling)
• University of Arizona- Site Number : 840015 — Tucson, Arizona, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 840013 — Chicago, Illinois, United States (enrolling)
• Arkansas Children's Hospital- Site Number : 840109 — Little Rock, Arkansas, United States (enrolling)
• Southern California Permanente Medical Group- Site Number : 840108 — Los Angeles, California, United States (enrolling)
• University of Arkansas for Medical Sciences- Site Number : 840113 — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital of Orange County- Site Number : 840074 — Orange, California, United States (enrolling)
• Phoenix Children's Hospital- Site Number : 840003 — Phoenix, Arizona, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 840011 — Chicago, Illinois, United States (enrolling)
• University of California at Irvine- Site Number : 840036 — Irvine, California, United States (enrolling)
• University of California San Francisco - Parnassus Campus- Site Number : 840051 — San Francisco, California, United States (enrolling)
• Stanford University Medical Center- Site Number : 840022 — Stanford, California, United States (enrolling)
• Yale University School of Medicine- Site Number : 840047 — New Haven, Connecticut, United States (enrolling)
• Children's National Medical Center - Washington- Site Number : 840067 — Washington D.C., District of Columbia, United States (enrolling)
• Investigational Site Number : 250012 — Washington D.C., District of Columbia, United States (enrolling)
• University Hematology Oncology- Site Number : 840075 — Coral Springs, Florida, United States (enrolling)
• University of Florida Pediatrics Genetics- Site Number : 840121 — Jacksonville, Florida, United States (enrolling)
• UC Davis MIND Institute- Site Number : 840010 — Sacramento, California, United States (enrolling)
• University Of Miami SOM- Site Number : 840006 — Miami, Florida, United States (enrolling)
• University of Florida-Genetics- Site Number : 840096 — Tampa, Florida, United States (enrolling)
• Tower Hematology Oncology Medical Group- Site Number : 840056 — Beverly Hills, California, United States (enrolling)
• Emory University School of Medicine- Human Genetics- Site Number : 840060 — Decatur, Georgia, United States (enrolling)
• University of Colorado at Denver Genetics- Site Number : 840068 — Aurora, Illinois, United States (enrolling)
• University of Iowa- Site Number : 840032 — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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