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A National Registry on Chinese Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05289245
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : March 21, 2022
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
Cystic fibrosis (CF) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. It is most commonly seen in Caucasians. Only a few Chinese CF patients have been described in literature, taking into account the large population of China. The main objectives of this study are to accurately evaluate the prevalence of CF, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.

Condition or disease
Pulmonary Function

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Cystic Fibrosis (CF-CHINA)
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : October 1, 2032
Estimated Study Completion Date : October 1, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients. [ Time Frame: 10 years ]
    Spirometry will be evaluated at baseline and through study completion, an average of 3 years.


Eligibility Criteria
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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
Study Population is from across the country of China.
Criteria

Inclusion Criteria:

Fulfilled WHO clinical diagnostic criteria for CF; Was in a stable phase with no respiratory infections for nearly 4 weeks; Subjects (or their guardians) signed informed consent.

Exclusion Criteria:

Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease

Contacts and Locations
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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): NCT05289245


Contacts
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Contact: Xinlun Tian, M.D. 86-10-69155039 tianxl@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: XinLun Tian, M.D.    86-10-69155039    tianxl@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05289245    
Other Study ID Numbers: XT 02
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases