IPFNCT07169253
Prognostic Score Comparison in IPF and HP
An observational study of IPF and Fibrotic Lung Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this retrospective observational study is to evaluate and compare the prognostic value of GAP, ILD-GAP, and CPI scoring systems in patients diagnosed with interstitial lung diseases (ILDs), specifically Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis, and non-fibrotic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IPF, Fibrotic Lung Disease, Hypersensitivity Pneumonitis
- What is being tested?
- GAP Index, ILD-GAP Index and Composite Physiologic Index (CPI)
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with Chronic Hypersensitivity Pneumonitis (fibrotic/non-fibrotic) and Idiopathic Pulmonary Fibrosis (IPF) by multidisciplinary discussion between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital.
Who may be able to join
- 40 patients diagnosed with IPF based on clinical features, laboratory findings, thoracic HRCT results, and/or histopathological confirmation, as determined by a multidisciplinary team discussion.
- 40 patients diagnosed with Fibrotic Hypersensitivity Pneumonitis based on clinical features, laboratory findings, and thoracic HRCT results, confirmed in a multidisciplinary team discussion.
- 40 patients diagnosed with Non-Fibrotic Hypersensitivity Pneumonitis based on clinical features, laboratory findings, and thoracic HRCT results, confirmed in a multidisciplinary team discussion.
- Male and female patients over 18 years of age.
Who cannot join
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: Comparison of GAP, ILD-GAP, and CPI in Idiopathic Pulmonary Fibrosis (IPF) and Hypersensitivity Pneumonitis (HP)
The goal of this retrospective observational study is to evaluate and compare the prognostic value of GAP, ILD-GAP, and CPI scoring systems in patients diagnosed with interstitial lung diseases (ILDs), specifically Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis, and non-fibrotic Hypersensitivity Pneumonitis.
The main questions it aims to answer are:
Read more
- Can GAP, ILD-GAP, and CPI scores accurately predict prognosis in IPF, fibrotic HP, and non-fibrotic HP patients?
- Are there differences in prognostic performance of these models across different ILD subtypes?
Researchers will compare the prognostic utility of GAP, ILD-GAP, and CPI scores between IPF, fibrotic HP, and non-fibrotic HP groups to see if one scoring system offers superior predictive power.
Participants:
- Adults aged ≥18 years
- Diagnosed between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
- 143 patients in total (IPF: 45, fibrotic HP: 26, non-fibrotic HP: 72)
Participants' data will include:
- Clinical and demographic characteristics
- Symptom duration
- Radiologic imaging findings
- Pulmonary function test (PFT) results
- Bronchoalveolar lavage (BAL) findings
- Histopathological diagnoses
Scoring systems will be calculated using standardized formulas as follows:
- GAP (Gender, Age, Physiology)
- ILD-GAP (modified GAP for CTD-ILDs)
- CPI (Composite Physiologic Index = 91 - [0.65 × %DLCO] - [0.53 × %FVC] + [0.34 × %FEV1])
Read the detailed description
This is a retrospective observational study designed to evaluate and compare the prognostic performance of three widely used scoring systems-Gender-Age-Physiology (GAP) Index, Interstitial Lung Disease-GAP (ILD-GAP) Index, and Composite Physiologic Index (CPI)-in patients diagnosed with interstitial lung diseases (ILDs). The study focuses specifically on three ILD subtypes: Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis (HP), and non-fibrotic HP.
The primary objective is to determine whether GAP, ILD-GAP, and CPI scores can accurately predict overall survival across these patient groups. A secondary aim is to compare the prognostic performance of the scoring systems to explore whether one model provides superior predictive value in specific ILD subtypes.
The study cohort includes adult patients (≥18 years) who were diagnosed between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital. A total of 143 patients were identified and included: 45 patients with IPF, 26 with fibrotic HP, and 72 with non-fibrotic HP.
Data collected for each patient include clinical and demographic characteristics, duration of symptoms, high-resolution computed tomography (HRCT) findings, pulmonary function test (PFT) results, bronchoalveolar lavage (BAL) findings, and histopathological diagnoses where available. The final diagnosis in each case was established through multidisciplinary team (MDT) discussions and/or histopathological confirmation.
The scoring systems were calculated using standardized formulas:
GAP Index: based on gender, age, and physiology (FVC % predicted, DLCO % predicted).
ILD-GAP Index: a modification of the GAP model for use in connective tissue disease-associated and other ILDs.
CPI (Composite Physiologic Index): calculated as 91 - (0.65 × %DLCO) - (0.53 × %FVC) + (0.34 × %FEV1).
By applying these validated prognostic models to a real-world ILD cohort, the study aims to provide insights into their relative accuracy, clinical utility, and potential limitations. Findings are expected to contribute to more precise prognostic assessment and risk stratification in patients with fibrotic and non-fibrotic ILDs.
- Being tested
- GAP Index, ILD-GAP Index, Composite Physiologic Index (CPI)
- Keywords
- Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, GAP, ILD-GAP, CPI
- Medical subject headings
- Alveolitis, Extrinsic Allergic, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAP IndexOther
For each patient in the IPF, fibrotic HP, and non-fibrotic HP groups, the GAP index was calculated based on age, gender, FVC, and DLCO values. According to the GAP index, patients were classified as Stage 1 (0-3 points), Stage 2 (4-5 points), and Stage 3 (6-8 points).
ILD-GAP IndexOther
In addition to the GAP parameters, the index was calculated to include the ILD subtype as well.
Composite Physiologic Index (CPI)Other
The CPI (Composite Physiologic Index) was calculated using the following formula:
CPI = 91 - (0.65 × %DLCO) - (0.53 × %FVC) + (0.34 × %FEV1).
DLCO: Diffusing Capacity of the Lung for Carbon Monoxide FVC: Forced Vital Capacity FEV₁: Forced Expiratory Volume in One Second
| Study group | Role | What they receive |
|---|---|---|
| IPF | The demographic data, symptom duration, clinical and laboratory findings, radiological images, BAL results, and histopathological diagnoses of patients diagnosed with IPF were evaluated according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of IPF and included in the IPF group. Receives: Other: GAP Index; Other: ILD-GAP Index; Other: Composite Physiologic Index (CPI) | |
| Fibrotic HP | Patients diagnosed with fibrotic HP were classified according to the 2020 ATS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of Hypersensitivity Pneumonitis in Adults. Receives: Other: GAP Index; Other: ILD-GAP Index; Other: Composite Physiologic Index (CPI) | |
| Non-fibrotic HP | Patients diagnosed with non-fibrotic HP were classified according to the 2020 ATS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of Hypersensitivity Pneumonitis in Adults. Receives: Other: GAP Index; Other: ILD-GAP Index; Other: Composite Physiologic Index (CPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic performance of the Gender-Age-Physiology (GAP) Index, Interstitial Lung Disease-GAP (ILD-GAP) Index, and Composite Physiologic Index (CPI) in predicting overall survival
Prognostic performance of GAP, ILD-GAP, and CPI scoring systems in predicting overall survival among patients with Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis, and non-fibrotic Hypersensitivity Pneumonitis.
Measured: Using data collected between October 2011 and October 2021
Secondary outcomes (4)
Association between clinical parameters and survival across ILD subgroups
Evaluation of the relationship between patient age, gender, presence of comorbidities, and symptom profiles and overall survival in IPF, fibrotic HP, and non-fibrotic HP groups using log-rank tests and Cox regression.
Measured: Using data collected between October 2011 and October 2021
Impact of CPI score increase on mortality risk
Assessment of the association between each 1-unit increase in Composite Physiologic Index (CPI) and the risk of mortality using Cox proportional hazards regression.
Measured: Using data collected between October 2011 and October 2021
Effect of GAP stage, gender, and CTD status on survival
Stratified survival analysis to investigate whether GAP stage (I-III), female gender, and absence of connective tissue disease are associated with longer survival, using Kaplan-Meier curves and multivariate Cox models.
Measured: Using data collected between October 2011 and October 2021
Comparison of prognostic performance (AUC) of GAP, ILD-GAP, and CPI across ILD subtypes
Receiver Operating Characteristic (ROC) analysis to compare the discriminative ability of GAP, ILD-GAP, and CPI scores in predicting mortality. AUC values were reported for each model across IPF, fibrotic HP, and non-fibrotic HP subgroups.
Measured: At baseline scoring and during follow-up (using data collected between October 2011 and October 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERDOGAN CETINKAYA, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169253
- Sponsor's protocol ID
- ILDPrognostic-Scores
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of GAP, ILD-GAP, and CPI in Idiopathic Pulmonary Fibrosis (IPF) and Hypersensitivity Pneumonitis (HP)
- ClinicalTrials.gov ID
- NCT07169253
- Acronym / sponsor ID
- ILDPrognostic-Scores
- Keywords
- Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, GAP, ILD-GAP, CPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Sep 2025 (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.
The goal of this retrospective observational study is to evaluate and compare the prognostic value of GAP, ILD-GAP, and CPI scoring systems in patients diagnosed with interstitial lung diseases (ILDs), specifically Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis, and non-fibrotic Hypersensitivity Pneumonitis.
The main questions it aims to answer are:
- Can GAP, ILD-GAP, and CPI scores accurately predict prognosis in IPF, fibrotic HP, and non-fibrotic HP patients?
- Are there differences in prognostic performance of these models across different ILD subtypes?
Researchers will compare the prognostic utility of GAP, ILD-GAP, and CPI scores between IPF, fibrotic HP, and non-fibrotic HP groups to see if one scoring system offers superior predictive power.
Participants:
- Adults aged ≥18 years
- Diagnosed between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
- 143 patients in total (IPF: 45, fibrotic HP: 26, non-fibrotic HP: 72)
Participants' data will include:
- Clinical and demographic characteristics
- Symptom duration
- Radiologic imaging findings
- Pulmonary function test (PFT) results
- Bronchoalveolar lavage (BAL) findings
- Histopathological diagnoses
Scoring systems will be calculated using standardized formulas as follows:
- GAP (Gender, Age, Physiology)
- ILD-GAP (modified GAP for CTD-ILDs)
- CPI (Composite Physiologic Index = 91 - [0.65 × %DLCO] - [0.53 × %FVC] + [0.34 × %FEV1])
Detailed description
This is a retrospective observational study designed to evaluate and compare the prognostic performance of three widely used scoring systems-Gender-Age-Physiology (GAP) Index, Interstitial Lung Disease-GAP (ILD-GAP) Index, and Composite Physiologic Index (CPI)-in patients diagnosed with interstitial lung diseases (ILDs). The study focuses specifically on three ILD subtypes: Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis (HP), and non-fibrotic HP.
The primary objective is to determine whether GAP, ILD-GAP, and CPI scores can accurately predict overall survival across these patient groups. A secondary aim is to compare the prognostic performance of the scoring systems to explore whether one model provides superior predictive value in specific ILD subtypes.
The study cohort includes adult patients (≥18 years) who were diagnosed between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital. A total of 143 patients were identified and included: 45 patients with IPF, 26 with fibrotic HP, and 72 with non-fibrotic HP.
Data collected for each patient include clinical and demographic characteristics, duration of symptoms, high-resolution computed tomography (HRCT) findings, pulmonary function test (PFT) results, bronchoalveolar lavage (BAL) findings, and histopathological diagnoses where available. The final diagnosis in each case was established through multidisciplinary team (MDT) discussions and/or histopathological confirmation.
The scoring systems were calculated using standardized formulas:
GAP Index: based on gender, age, and physiology (FVC % predicted, DLCO % predicted).
ILD-GAP Index: a modification of the GAP model for use in connective tissue disease-associated and other ILDs.
CPI (Composite Physiologic Index): calculated as 91 - (0.65 × %DLCO) - (0.53 × %FVC) + (0.34 × %FEV1).
By applying these validated prognostic models to a real-world ILD cohort, the study aims to provide insights into their relative accuracy, clinical utility, and potential limitations. Findings are expected to contribute to more precise prognostic assessment and risk stratification in patients with fibrotic and non-fibrotic ILDs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPF | – | Other: GAP Index, Other: ILD-GAP Index, Other: Composite Physiologic Index (CPI)The demographic data, symptom duration, clinical and laboratory findings, radiological images, BAL results, and histopathological diagnoses of patients diagnosed with IPF were evaluated according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of IPF and included in the IPF group. |
| Fibrotic HP | – | Other: GAP Index, Other: ILD-GAP Index, Other: Composite Physiologic Index (CPI)Patients diagnosed with fibrotic HP were classified according to the 2020 ATS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of Hypersensitivity Pneumonitis in Adults. |
| Non-fibrotic HP | – | Other: GAP Index, Other: ILD-GAP Index, Other: Composite Physiologic Index (CPI)Patients diagnosed with non-fibrotic HP were classified according to the 2020 ATS/JRS/ALAT Clinical Practice Guideline for the Diagnosis of Hypersensitivity Pneumonitis in Adults. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Chronic Hypersensitivity Pneumonitis (fibrotic/non-fibrotic) and Idiopathic Pulmonary Fibrosis (IPF) by multidisciplinary discussion between October 2011 and October 2021 at the University of Health Sciences Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital.
Key inclusion criteria (4 listed)
- 40 patients diagnosed with IPF based on clinical features, laboratory findings, thoracic HRCT results, and/or histopathological confirmation, as determined by a multidisciplinary team discussion.
- 40 patients diagnosed with Fibrotic Hypersensitivity Pneumonitis based on clinical features, laboratory findings, and thoracic HRCT results, confirmed in a multidisciplinary team discussion.
- 40 patients diagnosed with Non-Fibrotic Hypersensitivity Pneumonitis based on clinical features, laboratory findings, and thoracic HRCT results, confirmed in a multidisciplinary team discussion.
- Male and female patients over 18 years of age.
Key exclusion criteria (1 listed)
- Patients under 18 years of age
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 |
|---|---|---|
| GAP IndexFor each patient in the IPF, fibrotic HP, and non-fibrotic HP groups, the GAP index was calculated based on age, gender, FVC, and DLCO values. According to the GAP index, patients were classified as Stage 1 (0-3 points), Stage 2 (4-5 points), and Stage 3 (6-8 points). | Other | Fibrotic HP, IPF, Non-fibrotic HP |
| ILD-GAP IndexIn addition to the GAP parameters, the index was calculated to include the ILD subtype as well. | Other | Fibrotic HP, IPF, Non-fibrotic HP |
| Composite Physiologic Index (CPI)The CPI (Composite Physiologic Index) was calculated using the following formula: CPI = 91 - (0.65 × %DLCO) - (0.53 × %FVC) + (0.34 × %FEV1). DLCO: Diffusing Capacity of the Lung for Carbon Monoxide FVC: Forced Vital Capacity FEV₁: Forced Expiratory Volume in One Second | Other | Fibrotic HP, IPF, Non-fibrotic HP |
Primary outcome
Prognostic performance of the Gender-Age-Physiology (GAP) Index, Interstitial Lung Disease-GAP (ILD-GAP) Index, and Composite Physiologic Index (CPI) in predicting overall survival
Time frame: Using data collected between October 2011 and October 2021
Prognostic performance of GAP, ILD-GAP, and CPI scoring systems in predicting overall survival among patients with Idiopathic Pulmonary Fibrosis (IPF), fibrotic Hypersensitivity Pneumonitis, and non-fibrotic Hypersensitivity Pneumonitis.
4 secondary outcomes
Association between clinical parameters and survival across ILD subgroups
Time frame: Using data collected between October 2011 and October 2021
Impact of CPI score increase on mortality risk
Time frame: Using data collected between October 2011 and October 2021
Effect of GAP stage, gender, and CTD status on survival
Time frame: Using data collected between October 2011 and October 2021
Comparison of prognostic performance (AUC) of GAP, ILD-GAP, and CPI across ILD subtypes
Time frame: At baseline scoring and during follow-up (using data collected between October 2011 and October 2021)
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 11 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IPF and Fibrotic Lung Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 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 11 Sep 2025. 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 Turkey (Türkiye). 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?
Prognostic performance of the Gender-Age-Physiology (GAP) Index, Interstitial Lung Disease-GAP (ILD-GAP) Index, and Composite Physiologic Index (CPI) in predicting overall survival (time frame: Using data collected between October 2011 and October 2021). 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 11 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.