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Trial record 45 of 557 for:    Genetic AND family history

China Registry for Genetic / Metabolic Liver Diseases

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ClinicalTrials.gov Identifier: NCT03131427
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Beijing YouAn Hospital
Henan Provincial Hospital
Beijing Ditan Hospital
Hebei Medical University Third Hospital
Peking University First Hospital
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Nanfang Hospital of Southern Medical University
Logistics University of Chinese People's Armed Police Forces
Beijing Anzhen Hospital
West China Second University Hospital of Sichuan University
Jinshan Hospital of Fudan University
Fudan University
Information provided by (Responsible Party):
Jidong Jia, Beijing Friendship Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Genetic/Metabolic Liver Diseases Drug: Standard of care

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Nation-wide Hospital-based Registry:China Registry for Genetic / Metabolic Liver Diseases
Actual Study Start Date : June 13, 2015
Estimated Primary Completion Date : April 28, 2022
Estimated Study Completion Date : April 28, 2027


Group/Cohort Intervention/treatment
Wilson's Disease
Patients who were diagnosed or possibly diagnosed with Wilson's disease. The diagnosis can be made or possibly made on the basis of Wilson's disease scoring system proposed by the Working Party at the 8th International Meeting on Wilson's disease, Leipzig 2001.
Drug: Standard of care
Standard of care according to the updated national and/or international guidelines

Hereditary Hemochromatosis
Hereditary hemochromatosis can be clinically diagnosed if: ① transferrin saturation≥45% and/or elevated ferritin; ② iron overload in liver and/or spleen on magnetic resonance imaging (MRI) of liver or on liver histology; ③ exclude causes of secondary iron overload, such as alcoholic or other chronic liver disease, iron-overloading anemia, and parenteral iron overload.
Drug: Standard of care
Standard of care according to the updated national and/or international guidelines

Hereditary Hyperbilirubinemias
Hereditary hyperbilirubinemias involve four syndromes: Gilbert, Crigler-Najjar, Dubin-Johnson and Rotor, among which the first two are characterized by unconjugated hyperbilirubinemia and the second two by conjugated hyperbilirubinemia. Diagnosis of hereditary hyperbilirubinemia should exclude other causes of hyperbilirubinemia, such as obstructive bile duct (slerosing cholangitis, calculi, parasites), intrahepatic cholestasis(drugs, hepatitis, immune-mediated, infectious), acute or chronic hepatocellular injury(sepsis, parenteral nutrition, severe blood loss/hypotension, trauma, conjestive heart failure), increased bilirubin production(hemolysis, hematological disease), decreased bilirubin uptake (drugs, portosystemic shunting ), reduced conjugation activity (neonatal, thyroid disease, chronic hepatitis/inflammation, wilson's disease).
Drug: Standard of care
Standard of care according to the updated national and/or international guidelines

Inherited Cholestatic Liver Disease
Patients who were diagnosed or possibly diagnosed with Inherited cholestatic liver disease, including progressive familial intrahepatic cholestasis(PFIC) and benign recurrent intrahepatic cholestasis(BRIC).
Drug: Standard of care
Standard of care according to the updated national and/or international guidelines

Other genetic/metabolic liver diseases
Patients who were diagnosed or possibly diagnosed with genetic/metabolic liver diseases except for Wilson's disease, hereditary hemochromatosis, hereditary hyperbilirubinemias or inherited cholestatic liver disease.
Drug: Standard of care
Standard of care according to the updated national and/or international guidelines




Primary Outcome Measures :
  1. rate of liver-related events of each disease. [ Time Frame: 10 years ]
    Rates of cirrhosis, decompensation and hepatocellular carcinoma.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Quality of life [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry is a multicenter and observational study enrolling patients with genetic/metabolic liver disease across mailand China.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131427


Contacts
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Contact: Jidong Jia, MD 010-63139816 jia_jd@ccmu.edu.cn
Contact: Xiaojuan Ou, MD 010-63138315 ouxj16@sina.com

Locations
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China, Beijing
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Wen Xie, MD       xiewen6218@163.com   
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Yanwen Qin, MD       qinyanwen@126.com   
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yanling Yang, MD       organic.acid@126.com   
Beijing YouAn Hospital Recruiting
Beijing, Beijing, China, 100069
Contact: Sujun Zheng, MD       zhengsu.jun003@126.com   
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Yongpeng Chen, MD       cyp@smu.edu.cn   
China, Hebei
Hebei Medical University Third Hospital Recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Yuemin Nan, MD       nanyuemin@163.com   
China, Henan
Henan Provincial Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Jia Shang, MD       shangjia666@126.com   
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wei Jiang, MD       jiang.wei@zs-hospital.sh.cn   
Jinshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201508
Contact: Jianshe Wang, MD       jianshewang@sina.com   
China, Sichuan
West China Women's and Children's Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Chaomin Wan, MD       wcm0220@sina.com   
China, Tianjin
Affiliated Hospital, Logistics University of People's Armed Police Force Recruiting
Tianjin, Tianjin, China, 300163
Contact: Hai Li, MD       15202265600@163.com   
China, Xinjiang
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital Recruiting
Urumqi, Xinjiang, China, 830099
Contact: Xiaozhong Wang, MD       wxz125@sina.com   
Sponsors and Collaborators
Beijing Friendship Hospital
Beijing YouAn Hospital
Henan Provincial Hospital
Beijing Ditan Hospital
Hebei Medical University Third Hospital
Peking University First Hospital
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Nanfang Hospital of Southern Medical University
Logistics University of Chinese People's Armed Police Forces
Beijing Anzhen Hospital
West China Second University Hospital of Sichuan University
Jinshan Hospital of Fudan University
Fudan University
Investigators
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Principal Investigator: Jidong Jia, Doctor Beijing Friendship Hospital

Additional Information:

Publications:
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Responsible Party: Jidong Jia, Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03131427     History of Changes
Other Study ID Numbers: CR-GMLD
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jidong Jia, Beijing Friendship Hospital:
Wilson's Disease
Hereditary Hemochromatosis
Hereditary Hyperbilirubinemias
Inherited Cholestatic Liver Disease
Genetic Testing

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics