NCT05146934

Brief Summary

Application of artificial intelligence deep learning algorithm to analyze the relationship between hormone sensitivity of idiopathic interstitial pneumonia and imaging features of high resolution CT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

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

December 30, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
Last Updated

December 7, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

June 30, 2021

Last Update Submit

November 23, 2021

Conditions

Keywords

Hormone sensitivityimaging featuresartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • clinical data and imaging feature ratios in both groups

    clinical data including ages,gender,symptoms,signs,smoking history,complications,laboratory examination,lung function. Imaging feature including ground-glass opacity, reticulation, honeycomb and consolidation.

    3-6 months after medication

Secondary Outcomes (1)

  • the relationship between imaging feature ratios and hormone sensibility

    3-6 months after medication

Other Outcomes (1)

  • development of artificial intelligence algorithm model

    3-6 months after medication

Study Arms (2)

Hormone sensitive group

Prednisone, 0.5mg/kgqd, 3-6months

Radiation: high resolution CT

Hormone insensitivity group

Prednisone, 0.5mg/kgqd, 3-6months

Radiation: high resolution CT

Interventions

Ground glass,honeycomb,reticulation, consolidation

Hormone insensitivity groupHormone sensitive group

Eligibility Criteria

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

From June 1, 2012 to December 31, 2020, all inpatients with IIP were admitted to the respiratory and critical care department of the Third Hospital of Peking University. Total patients are 150, 45 patients using hormone, average age 62 years old, 21 male.

You may qualify if:

  • Clinical-pathological-radiology diagnosis of idiopathic interstitial pneumonia Hormone therapy was used; The follow-up data were complete, and the effect of hormone use could be judged.

You may not qualify if:

  • Lung infection disease; Heart failure; Connective tissue disease; IIP Without hormone therapy ; IIP but the follow-up data were incomplete, and the effect of hormone use could not be judged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Idiopathic Interstitial Pneumonias

Condition Hierarchy (Ancestors)

Idiopathic Pulmonary FibrosisPulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bei He

    Peking University Third Hospital Respiratory and critical care department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

December 7, 2021

Study Start

December 30, 2019

Primary Completion

June 1, 2021

Study Completion

June 30, 2021

Last Updated

December 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations