RecruitingNCT04398628

ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders

ATHN Transcends: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment in People With Non-Neoplastic Hematologic Disorders


Sponsor

American Thrombosis and Hemostasis Network

Enrollment

3,000 participants

Start Date

Sep 30, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.2,3,4,5 In 2019 alone, the FDA has issued approvals for 24 new therapies for congenital and acquired hematologic conditions.6 In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.7 With this increase in potential new therapies possible, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.8


Eligibility

Plain Language Summary

Simplified for easier understanding

ATHN Transcends is a large, long-term natural history study tracking people with non-cancerous blood disorders across multiple disease-specific cohorts. These include haemophilia A and B, von Willebrand disease, platelet disorders, clotting factor deficiencies, thrombosis/thrombophilia, and other blood conditions. By collecting detailed clinical and treatment data over time, the study aims to improve understanding of how these disorders progress and how current and future therapies affect outcomes. Participants of any age may enrol. You may be eligible if... - You have been diagnosed with a congenital or acquired blood disorder (any type) - You have unexplained abnormal bleeding on a standardised assessment tool - You have a connective tissue disorder with a bleeding tendency - You are already enrolled in the ATHNdataset registry - You qualify for one of the active disease-specific study arms You may NOT be eligible if... - You do not qualify for any currently active disease-specific arm - You are unable or unwilling to provide informed consent or assent - You are unwilling to perform the required study procedures Talk to your haematologist or haemophilia treatment centre about whether your blood disorder diagnosis and current treatment align with one of the active study cohorts.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(71)

Arizona Hemophilia and Thrombosis Treatment Center at Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Center for Bleeding Disorders

Little Rock, Arkansas, United States

Orthopaedic Institute for Children HTC

Los Angeles, California, United States

Childrens Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

University of California at Davis Hemophilia Treatment Center

Sacramento, California, United States

Loma Linda Hemoglobinopathy and Inherited Bleeding Disorder Program

San Bernardino, California, United States

Hemophilia & Thrombosis Treatment Center at UC San Diego Health

San Diego, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

University of California, San Francisco Hemophilia & Thrombosis Center

San Francisco, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale Hemophilia Treatment Center

New Haven, Connecticut, United States

Delaware Hemophilia Treatment Center

Wilmington, Delaware, United States

Georgetown University

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

Children's National Hemophilia Center

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

University of Florida Hemophilia Treatment Center

Gainesville, Florida, United States

University of Miami Comprehensive Hemophilia Treatment Center

Miami, Florida, United States

Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders

Orlando, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

St. Joseph's Hospital Center for Bleeding & Clotting Disorders

Tampa, Florida, United States

Comprehensive Bleeding Disorders Center at Emory University and Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Emory/Children's Health Care of Atlanta

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Bleeding and Clotting Disorders Institute

Peoria, Illinois, United States

Indiana Hemophilia and Thrombosis Center

Indianapolis, Indiana, United States

Iowa Hemophilia and Thrombosis Center

Iowa City, Iowa, United States

Louisiana Center for Bleeding and Clotting Disorders, Tulane University

New Orleans, Louisiana, United States

Maine Hemophilia and Thrombosis Center

Scarborough, Maine, United States

Johns Hopkins University Hemophilia Treatment Center

Baltimore, Maryland, United States

Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center

Boston, Massachusetts, United States

Central Michigan Children's Hospital of Michigan

Detroit, Michigan, United States

Henry Ford Health System Bleeding and Thrombosis Treatment Center

Detroit, Michigan, United States

Mayo Comprehensive Hemophilia Center

Rochester, Minnesota, United States

Children's Mercy Hospital - Kansas City

Kansas City, Missouri, United States

The John Bouhasin Center for Children with Bleeding Disorders

St Louis, Missouri, United States

Cure 4 The Kids Foundation

Las Vegas, Nevada, United States

Hemostasis and Thrombosis Center of Nevada

Reno, Nevada, United States

Newark Beth Israel Medical Center - Hemophilia Center

Newark, New Jersey, United States

University of New Mexico Ted R. Montoya Hemophilia & Thrombosis Program

Albuquerque, New Mexico, United States

Western New York BloodCare

Buffalo, New York, United States

Northwell Health Hemostasis and Thrombosis Center at Long Island Jewish and Cohen Children's Medical Center

Hyde Park, New York, United States

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

American Thrombosis and Hemostasis Network

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Comprehensive Hemophilia Treatment Center, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital

Charlotte, North Carolina, United States

East Carolina University Hemophilia Treatment Center

Greenville, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Akron Children's Hospital - Showers Center for Cancer & Blood Disorders

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Hemophilia & Thrombosis Center

Cincinnati, Ohio, United States

University of Cincinnati Medical Center Hemophilia Treatment Center

Cincinnati, Ohio, United States

University Hospitals Health System Cleveland

Cleveland, Ohio, United States

Nationwide Children's Hospital Columbus

Columbus, Ohio, United States

Dayton Children's Hemostasis and Thrombosis Center

Dayton, Ohio, United States

Northwest Ohio Hemophilia Treatment Center at the Toledo Hospital

Toledo, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Penn Comprehensive Hemophilia and Thrombophilia Program/Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital Hemostasis and Thrombosis Center

Providence, Rhode Island, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Children's Blood and Cancer Center of Central Texas

Austin, Texas, United States

North Texas Hemophilia and Thrombosis Program - Pediatric Program / Center for Cancer & Blood Disorders

Dallas, Texas, United States

North Texas Comprehensive Hemophilia Treatment Center

Dallas, Texas, United States

Gulf States Hemophilia and Thrombophilia Center

Houston, Texas, United States

Texas Children's Hemophilia & Thrombosis Center/Baylor College of Medicine

Houston, Texas, United States

South Texas Comprehensive Hemophilia and Thrombophilia Treatment Center

San Antonio, Texas, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States

Hemophilia Outreach Center Green Bay

Green Bay, Wisconsin, United States

Comprehensive Center for Bleeding Disorders

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04398628


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