NCT05289245

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Apr 2022Oct 2032

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

10.5 years

First QC Date

March 13, 2022

Last Update Submit

March 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.

    Spirometry will be evaluated at baseline and through study completion, an average of 3 years.

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Population is from across the country of China.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Xinlun Tian, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

October 1, 2032

Study Completion (Estimated)

October 1, 2032

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations