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NCT Number: NCT03131427

China Registry for Genetic / Metabolic Liver Diseases

CR-GMLD registry started on June 13, 2015 to collect cases of genetic/metabolic liver diseases from tertiary or secondary hospitals in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. Patients' whole blood and serum were collected for genetic testing and future researches. These patients will be followed-up every six to twelve months.

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Key information

Conditions

Genetic/Metabolic Liver Diseases Basal Ganglia Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hemochromatosis Hepatolenticular Degeneration Heredodegenerative Disorders, Nervous System Hyperbilirubinemia, Hereditary Iron Metabolism Disorders Iron Overload Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

This web-based database was launched on June 13, 2015 and consists of tertiary or secondary hospitals with special interest and expertise on managing genetic/metabolic liver diseases patients across mainland China. The main inclusion criteria for this registration are patients who were diagnosed or possibly diagnosed with Wilson's disease, hereditary hemochromatosis, hereditary hyperbilirubinemias, inherited cholestatic liver disease or other genetic/metabolic liver diseases. At the first time of data entry, demographics, medical history, biochemistry and hematology results, radiology reports, diagnosis and treatment information were recorded. Patients' whole blood and serum were collected for molecular genetic testing and future researches. Then the registered patients will receive standard of care and be followed-up every 6 to 12 months. On each visit, biochemical, radiological reports, as well as clinical progress were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who were diagnosed or possibly diagnosed with Wilson's disease, hereditary hemochromatosis, hereditary hyperbilirubinemias, inherited cholestatic liver disease or other genetic/metabolic liver diseases.

Exclusion criteria

Patients who are unable or unwilling to provide informed consent.

Treatment and study plan

Standard of care

Drug

Standard of care according to the updated national and/or international guidelines

Primary outcomes

  1. rate of liver-related events of each disease.

    Time frame: 10 years

    Rates of cirrhosis, decompensation and hepatocellular carcinoma.

Secondary outcomes

  1. Genotype profile in Chinese patients of each disease

    Time frame: 10 years

  2. Natural history of Chinese patients with each disease of different genotype

    Time frame: 10 years

  3. Causes of death in Chinese patients of each disease

    Time frame: 10 years

Other outcomes

  1. Quality of life

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jidong Jia, MD

CONTACT

[email protected]

010-63139816

Xiaojuan Ou, MD

CONTACT

[email protected]

010-63138315

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Ditan Hospital
  • Beijing YouAn Hospital
  • Fudan University
  • Hebei Medical University Third Hospital
  • Henan Provincial People's Hospital
  • Jinshan Hospital Fudan University
  • Logistics University of Chinese People's Armed Police Forces
  • Nanfang Hospital, Southern Medical University
  • Peking University First Hospital
  • West China Second University Hospital
  • Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Registry information

Official study title

A Nation-wide Hospital-based Registry:China Registry for Genetic / Metabolic Liver Diseases

Important dates

Study start
2015
Primary completion
2022
Study completion
2027
First posted
Apr 27, 2017
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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