NCT04516577

Brief Summary

By updating the chest HRCT scoring criteria of patients with pulmonary alveolar proteinosis, a new and more perfect system for evaluating the severity of alveolar proteinosis will be established.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

August 11, 2020

Last Update Submit

March 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The severity and prognosis of pulmonary alveolar proteinosis

    The second severity and prognosis score of PAP (SPSP II) involves the range and density of lesion in chest CT of patients

    From July 2020 to December 2021

Study Arms (3)

Shanghai Pulmonary Hospital

Shanghai Pulmonary Hospital is a hospital specializing in the treatment of lung diseases. Many patients with pulmonary alveolar proteinosis receive treatment in this hospital.

Other: Assesssing the severity of pulmonary alveolar proteinosis

Peking Union Medical College Hospital

Peking Union Medical College Hospital is a famous hospital in China. Many patients with rare pulmonary disease receive treatment in this hospital.

Other: Assesssing the severity of pulmonary alveolar proteinosis

Nanjing Drum Tower Hospital

The Department of Respiratory and Critical Care Medicine of Nanjing Drum Tower Hospital has been focusing on the research of rare pulmonary diseases for many years.

Interventions

Three severity scores will be used to assess the severity of patients with pulmonary alveolar proteinosis.

Peking Union Medical College HospitalShanghai Pulmonary Hospital

Eligibility Criteria

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

The patients had be diagnosed with autoimmune pulmonary alveolar proteinosis. Every patient had a complete medical history, chest HRCT, pulmonary function and arterial blood gas analysis.

You may qualify if:

  • The patients had be diagnosed with autoimmune pulmonary alveolar proteinosis through pathology or bronchial alveolar lavage fluid (BALF).
  • The patients are old than 18 year.
  • Every patient had a complete medical history, chest HRCT, pulmonary function and arterial blood gas analysis.
  • The patients have high level antibody of GM-CSF in serum or BALF.

You may not qualify if:

  • The patients had a congenital or secondary pulmonary alveolar proteinosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

  • Bai JW, Huang JN, Shi SY, Ge A, Lu HW, Sun XL, Gu SY, Liang S, Cheng KB, Tian XL, Xiao YL, Xu KF, Xu JF. Updated severity and prognosis score of pulmonary alveolar proteinosis: A multi-center cohort study in China. Front Med (Lausanne). 2023 Feb 7;10:1058001. doi: 10.3389/fmed.2023.1058001. eCollection 2023.

MeSH Terms

Conditions

Pulmonary Alveolar Proteinosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Xinlun Tian, Dr

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR
  • Yonglong Xiao, Dr

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Respiratory and Critical Care Medicine

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 18, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations