NCT03643653

Brief Summary

The investigators meant to establish a multi-centered bronchiectasis patient registry for Chinese bronchiectasis patients. This would be the first bronchiectasis registry in China. Patients with all kinds of bronchiectasis would be enrolled.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

6.9 years

First QC Date

August 16, 2018

Last Update Submit

October 10, 2023

Conditions

Bronchiectasis

Keywords

Bronchiectasismulti-centered registry

Outcome Measures

Primary Outcomes (1)

  • Number of patients enrolled in the registry

    To establish a multi-centered bronchiectasis registry in Shanghai

    3 years

Secondary Outcomes (10)

  • Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.)

    recorded at baseline and re-tested every year, up to 3 years.

  • Exacerbation

    up to 3 years

  • Aetiology

    at baseline

  • Microbiology

    At least 1 year before enrollment and 3 years during the follow-up

  • Comorbidity

    At baseline and updated every year for up to 3 years

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with all-cause bronchiectasis would be included, such as those with tuberculosis history and genetic disorders.

You may qualify if:

  • Patients diagnosed with bronchiectasis according to 'non-cystic fibrosis bronchiectasis guideline' published by British Thoracic Society in 2010.
  • Patients who are willing to sign the consent form and participate in the study.

You may not qualify if:

  • Patients with incomplete essential information, which is needed for the integrity of data analysis. Essential information include CT images, respiratory sample cultures, spirometry and exacerbation history for at least one year.
  • Patients under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

Related Publications (2)

  • Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.

    PMID: 27730179RESULT

  • Gao YH, Lu HW, Mao B, Guan WJ, Song YL, Li YY, Wang DX, Wang B, Gu HY, Li W, Luo H, Wang LW, Li F, Guo FX, Zhang M, Jie ZJ, Hang JQ, Yang C, Ren T, Yuan Z, Meng QW, Jia Q, Chen Y, Chen RC, Qu JM, Xu JF. The Establishment of China Bronchiectasis Registry and Research Collaboration (BE-China): Protocol of a prospective multicenter observational study. Respir Res. 2022 Dec 3;23(1):328. doi: 10.1186/s12931-022-02254-9.

    PMID: 36463140DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood would be drawn and stored at - 80℃

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Jin-Fu Xu, MD

    Shanghai Pulmonary Hospital, Shanghai, China

    STUDY CHAIR

Central Study Contacts

Jin-Fu Xu, MD

CONTACT

+86-13321922898jfxucn@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Respiratory and Critical Care Medicine

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 23, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)