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RECRUITING
NCT00358943

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

Sponsor: Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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.

Official title: Gaucher Disease Registry Protocol

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

12000

Start Date

1991-04-01

Completion Date

2034-01-31

Last Updated

2026-01-06

Healthy Volunteers

No

Locations (318)

Phoenix Children's Hospital- Site Number : 840003

Phoenix, Arizona, United States

University of Arizona- Site Number : 840015

Tucson, Arizona, United States

Arkansas Childrens Hospital- Site Number : 840109

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences- Site Number : 840113

Little Rock, Arkansas, United States

Tower Hematology/Oncology Medical Group- Site Number : 840056

Beverly Hills, California, United States

University of California at Irvine- Site Number : 840036

Irvine, California, United States

Southern California Permanente Medical Group- Site Number : 840108

Los Angeles, California, United States

USC Health Sciences Center Dept of Genetics- Site Number : 840082

Los Angeles, California, United States

Children's Hospital of Orange County- Site Number : 840074

Orange, California, United States

Stanford Unviersity MC Dept of Genetics- Site Number : 840022

Palo Alto, California, United States

UC Davis MIND Institute- Site Number : 840010

Sacramento, California, United States

Kaiser Permanente Hospital- Site Number : 840042

Sacramento, California, United States

University of California at San Diego- Site Number : 840007

San Diego, California, United States

University of California at San Francisco- Site Number : 840051

San Francisco, California, United States

Yale - Site Number : 840047

New Haven, Connecticut, United States

Children's National Medical Center- Site Number : 840067

Washington D.C., District of Columbia, United States

University Hematology Oncology- Site Number : 840075

Coral Springs, Florida, United States

University of Florida Pediatrics Genetics- Site Number : 840121

Jacksonville, Florida, United States

The Atwal Clinic- Site Number : 840112

Jacksonville, Florida, United States

University Of Miami SOM- Site Number : 840006

Miami, Florida, United States

University of Florida-Genetics- Site Number : 840096

Tampa, Florida, United States

Pediatric Endocrine Associates- Site Number : 840017

Tampa, Florida, United States

Emory University School of Medicine- Human Genetics- Site Number : 840060

Decatur, Georgia, United States

University of Colorado at Denver Genetics- Site Number : 840068

Aurora, Illinois, United States

Ann and Robert Lurie Children's Hospital- Site Number : 840011

Chicago, Illinois, United States

Ann and Robert Lurie Children's Hospital- Site Number : 840013

Chicago, Illinois, United States

Rush University Medical Center Genetics- Site Number : 840079

Chicago, Illinois, United States

Indianapolis University School of Medicine- Site Number : 840027

Indianapolis, Indiana, United States

University of Iowa- Site Number : 840032

Iowa City, Iowa, United States

University of Louisville- Genetics- Site Number : 840030

Louisville, Kentucky, United States

Tulane University Medical Center- Site Number : 840001

New Orleans, Louisiana, United States

Maine Medical Center Pediatrics- Site Number : 840064

Portland, Maine, United States

John Hopkins- Site Number : 840044

Baltimore, Maryland, United States

Massachusetts General Hospital-Genetics- Site Number : 840062

Boston, Massachusetts, United States

Boston Children's Hospital - PIN- Site Number : 840092

Boston, Massachusetts, United States

University of Michigan Pediatrics- Site Number : 840107

Ann Arbor, Michigan, United States

Children's Hospital of Michigan- Site Number : 840066

Detroit, Michigan, United States

Spectrum for Health- Site Number : 840019

Grand Rapids, Michigan, United States

Infusion Associates- Site Number : 840050

Grand Rapids, Michigan, United States

Children's Health Care- Site Number : 840114

Minneapolis, Minnesota, United States

Children's Hospital and Clinics of Minnesota- Site Number : 840046

Minneapolis, Minnesota, United States

University of Minnesota Medical Center Pediatrics- Site Number : 840076

Minneapolis, Minnesota, United States

University of Missouri Health System Department of Genetics- Site Number : 840031

Columbia, Missouri, United States

Children's Mercy Hospital- Pediatrics- Site Number : 840063

Kansas City, Missouri, United States

Washington University of St. Louis- Site Number : 840100

St Louis, Missouri, United States

University of Nebraska Medical Center- Pediatrics- Site Number : 840084

Omaha, Nebraska, United States

Children's Specialty Center of Nevada- Site Number : 840008

Las Vegas, Nevada, United States

Cooper Health Center- Site Number : 840098

Camden, New Jersey, United States

Joseph M. Sanzari Children's Hospital- Site Number : 840101

Hackensack, New Jersey, United States

Atlantic Health System- Site Number : 840099

Morristown, New Jersey, United States

St. Peter's University Hospital- Site Number : 840016

New Brunswick, New Jersey, United States

St. Joseph's Children's Hospital- Site Number : 840057

Paterson, New Jersey, United States

Northwell Health- Site Number : 840102

Manhasset, New York, United States

New York University School Of Medicine- Site Number : 840040

New York, New York, United States

Metropolitan Hospital Center- Site Number : 840110

New York, New York, United States

Mt. Sinai School of Medicine- Site Number : 840005

New York, New York, United States

Columbia University Irving Medical Center- Site Number : 840125

New York, New York, United States

University of Rochester Medical Center SOM- Site Number : 840105

Rochester, New York, United States

State University of New York- Site Number : 840052

Syracuse, New York, United States

New York Medical College- Site Number : 840039

Valhalla, New York, United States

Carolinas Medical Center Hospital- Site Number : 840065

Charlotte, North Carolina, United States

Duke University Medical Center Genetics Dept- Site Number : 840037

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center- Site Number : 840026

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center- Site Number : 840119

Cleveland, Ohio, United States

Cleveland Clinic Foundation Pediatrics- Site Number : 840048

Cleveland, Ohio, United States

Nationwide Children's Hospital - PIN- Site Number : 840091

Columbus, Ohio, United States

LSD Data Registry Site LLC- Site Number : 840094

Dublin, Ohio, United States

Oregon Health & Science University (OHSU)- Site Number : 840080

Portland, Oregon, United States

Penn State Health Milton South Hershey Medical Center- Site Number : 840126

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia HUP Medical Genetics- Site Number : 840089

Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia- Site Number : 840034

Philadelphia, Pennsylvania, United States

University of Pittsburgh- Site Number : 840023

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital Genetics- Site Number : 840053

Providence, Rhode Island, United States

Greenwood Genetcs- Site Number : 840055

Greenville, South Carolina, United States

Vanderbilt University Hospital-Pediatrics- Site Number : 840049

Nashville, Tennessee, United States

Baylor Research Center- Site Number : 840058

Dallas, Texas, United States

Cook Children's Health Care System- Site Number : 840024

Fort Worth, Texas, United States

University of Utah Department of Medical Genetics- Site Number : 840043

Salt Lake City, Utah, United States

University of Virginia School of Medicine-Pediatrics- Site Number : 840078

Charlottesville, Virginia, United States

O&O Alpan, LLC- Site Number : 840025

Fairfax, Virginia, United States

Children's Hospital of the Kings Daughters- Site Number : 840072

Norfolk, Virginia, United States

Seattle Children's Hospital- Site Number : 840028

Seattle, Washington, United States

University Of Washington Medical Center- Site Number : 840059

Seattle, Washington, United States

Multicare Health System ¿ Mary Bridge Childrens Hospital- Site Number : 840115

Tacoma, Washington, United States

Children's Hospital of Wisconsin-Pediatrics- Site Number : 840054

Milwaukee, Wisconsin, United States

Investigational Site Number : 150661

CABA, Buenos Aires, Argentina

Investigational Site Number : 032014

Ciudad de Buenos Aires, Buenos Aires, Argentina

Investigational Site Number : 032003

La Plata, Buenos Aires, Argentina

Investigational Site Number : 151085

Sarandí, Buenos Aires, Argentina

Investigational Site Number : 032012

Buenos Aires, Argentina

Investigational Site Number : 154176

Corrientes, Argentina

Investigational Site Number : 032011

Córdoba, Argentina

Investigational Site Number : 151431

Sydney, New South Wales, Australia

Investigational Site Number : 151069

Westmead, New South Wales, Australia

Investigational Site Number : 151010

Brisbane, Queensland, Australia

Investigational Site Number : 151491

Douglas, Queensland, Australia

Investigational Site Number : 151002

Adelaide, South Australia, Australia

Investigational Site Number : 151725

Hobart, Tasmania, Australia

Investigational Site Number : 151011

Clayton, Victoria, Australia

Investigational Site Number : 151008

Parkville, Victoria, Australia

Investigational Site Number : 151015

Murdoch, Western Australia, Australia

Investigational Site Number : 150722

Antwerp, Belgium

Investigational Site Number : 151156

Bruges, Belgium

Investigational Site Number : 151796

Brussels, Belgium

Investigational Site Number : 150944

Brussels, Belgium

Investigational Site Number : 152345

Brussels, Belgium

Investigational Site Number : 150517

Brussels, Belgium

Investigational Site Number : 154285

Edegem, Belgium

Investigational Site Number : 151134

Ghent, Belgium

Investigational Site Number : 151668

Leuven, Belgium

Hospital das Clínicas da Universidade Federal do Paraná - HCUFPR- Site Number : 076010

Curitiba, Paraná, Brazil

Hospital de Clinicas de Porto Alegre- Site Number : 076007

Porto Alegre, Rio Grande do Sul, Brazil

Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 076012

Campinas, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 076001

Ribeirão Preto, São Paulo, Brazil

Faculdade De Medicina - Unicamp- Site Number : 076005

Campinas, Brazil

HEMORIO- Site Number : 076006

Rio de Janeiro, Brazil

Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 076002

São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 076008

São Paulo, Brazil

Investigational Site Number : 100001

Sofia, Bulgaria

Investigational Site Number : 151164

Sofia, Bulgaria

Investigational Site Number : 124014

Calgary, Alberta, Canada

Investigational Site Number : 124002

Edmonton, Alberta, Canada

Investigational Site Number : 124010

Vancouver, British Columbia, Canada

Investigational Site Number : 124011

Vancouver, British Columbia, Canada

Investigational Site Number : 124019

Winnipeg, Manitoba, Canada

Investigational Site Number : 124022

Moncton, New Brunswick, Canada

Investigational Site Number : 124024

Kingston, Ontario, Canada

Investigational Site Number : 124005

Kingston, Ontario, Canada

Investigational Site Number : 124021

London, Ontario, Canada

Investigational Site Number : 124006

Toronto, Ontario, Canada

Investigational Site Number : 124013

Toronto, Ontario, Canada

Investigational Site Number : 124001

Sherbrooke, Quebec, Canada

Investigational Site Number : 151787

Beijing, China

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 156003

Beijing, China

Investigational Site Number : 152357

Guangzhou, China

Investigational Site Number : 1560002

Guangzhou, China

Investigational Site Number : 152358

Hangzhou, China

Investigational Site Number : 152359

Hangzhou, China

Investigational Site Number : 157252

Nanjing, China

Investigational Site Number : 152356

Shanghai, China

Investigational Site Number : 150899

Shanghai, China

Investigational Site Number : 170004

Bogotá, Colombia

Investigational Site Number : 1910001

Zagreb, Croatia

Investigational Site Number : 1910002

Zagreb, Croatia

Investigational Site Number : 1910003

Zagreb, Croatia

Investigational Site Number : 150809

Prague, Czechia

Investigational Site Number : 151229

København Ø, Denmark

Investigational Site Number : 2140001

Santo Domingo, Dominican Republic

Investigational Site Number : 818007

Al Mansurah, Egypt

Investigational Site Number : 5748

Alexandria, Egypt

Investigational Site Number : 9889

Ash Sharqiyah, Egypt

Investigational Site Number : 9888

Asyut, Egypt

Investigational Site Number : 9829

Cairo, Egypt

Investigational Site Number : 8345

Cairo, Egypt

Investigational Site Number : 9830

Cairo, Egypt

Investigational Site Number : 250004

Besançon, France

Investigational Site Number : 250008

Bordeaux, France

Investigational Site Number : 250005

Brest, France

Investigational Site Number : 250014

Bron, France

Investigational Site Number : 250002

Caen, France

Investigational Site Number : 250001

Clichy, France

Investigational Site Number : 250003

Garches, France

Investigational Site Number : 250009

Lyon, France

Investigational Site Number : 250011

Marseille, France

Investigational Site Number : 2500013

Montpellier, France

Investigational Site Number : 250006

Nantes, France

Investigational Site Number : 250007

Paris, France

Investigational Site Number : 250010

Paris, France

Investigational Site Number : 250012

Rennes, France

Investigational Site Number : 250018

Strasbourg, France

Investigational Site Number : 250017

Toulouse, France

Investigational Site Number : 250016

Tours, France

Investigational Site Number : 151686

Berlin, Germany

Investigational Site Number : 150783

Düsseldorf, Germany

Investigational Site Number : 154150

Giessen, Germany

Investigational Site Number : 151369

Hamburg, Germany

Investigational Site Number : 151368

Hamburg, Germany

Investigational Site Number : 150031

Mainz, Germany

Investigational Site Number : 150432

Oberhausen, Germany

Investigational Site Number : 300002

Athens, Greece

Investigational Site Number : 300004

Athens, Greece

Investigational Site Number : 300003

Pátrai, Greece

Investigational Site Number : 300001

Thessaloniki, Greece

Investigational Site Number : 344001

Kowloon, Hong Kong

Investigational Site Number : 3480006

Budapest, Hungary

Investigational Site Number : 3480003

Létavértes, Hungary

Investigational Site Number : 3480007

Nyíregyháza, Hungary

Investigational Site Number : 3480008

Székesfehérvár, Hungary

Investigational Site Number : 356003

Ahmedabad, India

Investigational Site Number : 356004

Jaipur, India

Investigational Site Number : 356001

Kolkata, India

Investigational Site Number : 356005

Mumbai, India

Investigational Site Number : 3560006

Secunderabad, India

Investigational Site Number : 356002

Vellore, India

Investigational Site Number : 360001

Jakarta, Indonesia

Investigational Site Number : 3760003

Haifa, Israel

Investigational Site Number : 3760001

Jerusalem, Israel

Investigational Site Number : 3760002

Petah Tikva, Israel

Investigational Site Number : 380007

Rome, Roma, Italy

Investigational Site Number : 380014

Sassari, Sardinia, Italy

Investigational Site Number : 380008

Catania, Italy

Investigational Site Number : 380009

Florence, Italy

Investigational Site Number : 380006

Genova, Italy

Investigational Site Number : 380004

Milan, Italy

Investigational Site Number : 380005

Modena, Italy

Investigational Site Number : 380002

Monza, Italy

Investigational Site Number : 380011

Monza, Italy

Investigational Site Number : 380010

Naples, Italy

Investigational Site Number : 380003

Padova, Italy

Investigational Site Number : 380001

Udine, Italy

Investigational Site Number : 153205

Abeno-ku, Osaka, Japan

Investigational Site Number : 153203

Yonago-shi, Tottori, Japan

Investigational Site Number : 153217

Chiba, Japan

Investigational Site Number : 153204

Tokyo, Japan

Investigational Site Number : 4000001

Amman, Jordan

Investigational Site Number : 154225

Kuwait City, Kuwait

Investigational Site Number : 422001

Beirut, Lebanon

Investigational Site Number : 4220004

Beirut, Lebanon

Investigational Site Number : 154237

Vilnius, Lithuania

Investigational Site Number : 458002

Kuala Lumpur, Malaysia

Investigational Site Number : 458001

Kuala Pahang, Malaysia

Investigational Site Number : 150149

Amsterdam, Netherlands

Investigational Site Number : 151171

Amsterdam, Netherlands

Investigational Site Number : 154264

Karachi, Pakistan

Investigational Site Number : 154266

Lahore, Pakistan

Investigational Site Number : 604001

Arequipa, Peru

Investigational Site Number : 604002

Callao, Peru

Investigational Site Number : 608001

Manila, Philippines

Investigational Site Number : 150575

Warsaw, Poland

Investigational Site Number : 620003

Coimbra, Portugal

Investigational Site Number : 620004

Lisbon, Portugal

Investigational Site Number : 620009

Ponta Delgada, Portugal

Investigational Site Number : 642001

Cluj-Napoca, Romania

Investigational Site Number : 151188

Cluj-Napoca, Romania

Investigational Site Number : 642002

Cluj-Napoca, Romania

Investigational Site Number : 643001

Moscow, Russia

Investigational Site Number : 643002

Saint Petersburg, Russia

Investigational Site Number : 682002

Al Mubarraz, Saudi Arabia

Investigational Site Number : 682003

Jeddah, Saudi Arabia

Investigational Site Number : 682004

Mecca, Saudi Arabia

Investigational Site Number : 688001

Belgrade, Serbia

Investigational Site Number : 688002

Belgrade, Serbia

Investigational Site Number : 688003

Belgrade, Serbia

Investigational Site Number : 688005

Belgrade, Serbia

Investigational Site Number : 688004

Niš, Serbia

Investigational Site Number : 702001

Singapore, Singapore

Investigational Site Number : 703001

Bratislava, Slovakia

Investigational Site Number : 154138

Johannesburg, South Africa

Investigational Site Number : 710-003

Johannesburg, South Africa

Investigational Site Number : 150346

Sandton, South Africa

Investigational Site Number : 154208

Yangsan, Gyeongsangnam-do, South Korea

Investigational Site Number : 153180

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 153196

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 153191

Daejeon, South Korea

Investigational Site Number : 151149

Seoul, South Korea

Investigational Site Number : 153212

Seoul, South Korea

Investigational Site Number : 153222

Seoul, South Korea

Investigational Site Number : 154146

A Coruña, A Coruña [La Coruña], Spain

Investigational Site Number : 153237

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 154147

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 154119

Alcorcón, Madrid, Spain

Investigational Site Number : 153213

Vigo, Pontevedra [Pontevedra], Spain

Investigational Site Number : 153215

Seville, Sevilla, Spain

Investigational Site Number : 153219

Seville, Sevilla, Spain

Investigational Site Number : 154163

Madrid, Spain

Investigational Site Number : 154236

Madrid, Spain

Investigational Site Number : 151524

Madrid, Spain

Investigational Site Number : 153251

Madrid, Spain

Investigational Site Number : 154199

Madrid, Spain

Investigational Site Number : 154160

Madrid, Spain

Investigational Site Number : 154145

Sabadell, Spain

Investigational Site Number : 154205

Valencia, Spain

Investigational Site Number : 154238

Zaragoza, Spain

Investigational Site Number : 153216

Zaragoza, Spain

Investigational Site Number : 154095

Borås, Sweden

Investigational Site Number : 151726

Malmo, Sweden

Investigational Site Number : 154092

Norrköping, Sweden

Investigational Site Number : 157237

Aarau, Switzerland

Investigational Site Number : 157045

Bern, Switzerland

Investigational Site Number : 157244

Lausanne, Switzerland

Investigational Site Number : 157241

Zurich, Switzerland

Investigational Site Number : 151500

Chiayi City, Taiwan

Investigational Site Number : 154093

Chiayi City, Taiwan

Investigational Site Number : 152152

Hualien City, Taiwan

Investigational Site Number : 152244

Kaohsiung City, Taiwan

Investigational Site Number : 152246

Kaohsiung City, Taiwan

Investigational Site Number : 151534

New Taipei City, Taiwan

Investigational Site Number : 151181

Taichung, Taiwan

Investigational Site Number : 151179

Taichung, Taiwan

Investigational Site Number : 153248

Tainan, Taiwan

Investigational Site Number : 152153

Tainan, Taiwan

Investigational Site Number : 151182

Taipei, Taiwan

Investigational Site Number : 152321

Taipei, Taiwan

Investigational Site Number : 152226

Taipei, Taiwan

Investigational Site Number : 153158

Tao Yuan County, Taiwan

Investigational Site Number : 764003

Bangkok, Thailand

Investigational Site Number : 764004

Bangkok, Thailand

Investigational Site Number : 764001

Bangkok, Thailand

Investigational Site Number : 764005

Khon Kaen, Thailand

Investigational Site Number : 792006

Adana, Turkey (Türkiye)

Investigational Site Number : 792005

Ankara, Turkey (Türkiye)

Investigational Site Number : 792001

Ankara, Turkey (Türkiye)

Investigational Site Number : 792002

Ankara, Turkey (Türkiye)

Investigational Site Number : 792004

Istanbul, Turkey (Türkiye)

Investigational Site Number : 792007

Izmir, Turkey (Türkiye)

Investigational Site Number : 792003

Malatya, Turkey (Türkiye)

Investigational Site Number : 7840001

Dubai, United Arab Emirates

Investigational Site Number : 151340

Cambridge, Cambridgeshire, United Kingdom

Investigational Site Number : 152287

Birmingham, England, United Kingdom

Investigational Site Number : 152361

Salford, Manchester, United Kingdom

Investigational Site Number : 154240

Birmingham, United Kingdom

Investigational Site Number : 151123

London, United Kingdom

Investigational Site Number : 151646

London, United Kingdom

Investigational Site Number : 150303

London, United Kingdom

Investigational Site Number : 150455

Manchester, United Kingdom

Investigational Site Number : 154212

Hanoi, Vietnam

Investigational Site Number : 704002

Ho Chi Minh City, Vietnam