Idiopathic Interstitial PneumoniaIIPNCT05146934
The Relationship Between Hormone Sensitivity and Imaging of Idiopathic Interstitial Pneumonia by Artificial Intelligence
An observational study of Idiopathic Interstitial Pneumonia, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Idiopathic Interstitial Pneumonia
- What is being tested?
- high resolution CT
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the detailed description
Methods: the medical records and chest high-resolution CT images of patients with idiopathic interstitial pneumonia admitted to the respiratory department of the Third Hospital of Peking University from June 1, 2012 to December 31, 2020 were retrospectively analyzed.Application of artificial intelligence deep learning neural convolution network method to create recognition technology of different imaging features.Including ground glass, mesh, honeycomb, nodule or consolidation, the model was established. IIP patients were divided into hormone sensitive group and hormone insensitive group according to whether the use of hormone was effective or not.Logistic regression analysis was used to analyze the correlation between statistically significant parameters and hormone sensitivity.Artificial intelligence was used to establish the correlation model between imaging features and clinical data and hormone sensitivity.
- Conditions
- Idiopathic Interstitial Pneumonia
- Being tested
- high resolution CT
- Keywords
- Hormone sensitivity, imaging features, artificial intelligence
- Medical subject headings
- Idiopathic Interstitial Pneumonias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high resolution CTRadiation
Ground glass，honeycomb，reticulation, consolidation
| Study group | Role | What they receive |
|---|---|---|
| Hormone sensitive group | Prednisone, 0.5mg/kgqd, 3-6months Receives: Radiation: high resolution CT | |
| Hormone insensitivity group | Prednisone, 0.5mg/kgqd, 3-6months Receives: Radiation: high resolution CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months after medication
Secondary outcomes (1)
the relationship between imaging feature ratios and hormone sensibility
Logistic regression analyzing the relationship between imaging feature ratios and hormone sensibility.
Measured: 3-6 months after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start30 Dec 2019
- Primary completion1 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Interstitial PneumoniaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bei He, Principal investigator, Peking University Third Hospital Respiratory and critical care department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146934
- Sponsor's protocol ID
- LM2019173
- Acronym
- IIP
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Hormone Sensitivity and Imaging of Idiopathic Interstitial Pneumonia by Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05146934
- Acronym / sponsor ID
- IIP / LM2019173
- Conditions
- Idiopathic Interstitial Pneumonia
- Keywords
- Hormone sensitivity, imaging features, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methods: the medical records and chest high-resolution CT images of patients with idiopathic interstitial pneumonia admitted to the respiratory department of the Third Hospital of Peking University from June 1, 2012 to December 31, 2020 were retrospectively analyzed.Application of artificial intelligence deep learning neural convolution network method to create recognition technology of different imaging features.Including ground glass, mesh, honeycomb, nodule or consolidation, the model was established. IIP patients were divided into hormone sensitive group and hormone insensitive group according to whether the use of hormone was effective or not.Logistic regression analysis was used to analyze the correlation between statistically significant parameters and hormone sensitivity.Artificial intelligence was used to establish the correlation model between imaging features and clinical data and hormone sensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone sensitive group | – | Radiation: high resolution CTPrednisone, 0.5mg/kgqd, 3-6months |
| Hormone insensitivity group | – | Radiation: high resolution CTPrednisone, 0.5mg/kgqd, 3-6months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high resolution CTGround glass，honeycomb，reticulation, consolidation | Radiation | Hormone insensitivity group, Hormone sensitive group |
Primary outcome
clinical data and imaging feature ratios in both groups
Time frame: 3-6 months after medication
clinical data including ages，gender，symptoms,signs,smoking history,complications,laboratory examination，lung function. Imaging feature including ground-glass opacity, reticulation, honeycomb and consolidation.
1 secondary outcome
the relationship between imaging feature ratios and hormone sensibility
Time frame: 3-6 months after medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bei He principal investigator
Peking University Third Hospital Respiratory and critical care department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Interstitial Pneumonia, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical data and imaging feature ratios in both groups (time frame: 3-6 months after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.