跳至主要内容
临床试验/NCT07169253
NCT07169253已完成不适用

Comparison of GAP, ILD-GAP, and CPI in Idiopathic Pulmonary Fibrosis (IPF) and Hypersensitivity Pneumonitis (HP)

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
1
主要终点
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

研究概览

简要总结

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])

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients under 18 years of age

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Association between clinical parameters and survival across ILD subgroups(Using data collected between October 2011 and October 2021)
  • Impact of CPI score increase on mortality risk(Using data collected between October 2011 and October 2021)
  • Effect of GAP stage, gender, and CTD status on survival(Using data collected between October 2011 and October 2021)
  • Comparison of prognostic performance (AUC) of GAP, ILD-GAP, and CPI across ILD subtypes(At baseline scoring and during follow-up (using data collected between October 2011 and October 2021))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ERDOGAN CETINKAYA

Prof. Dr.

Saglik Bilimleri Universitesi

研究点 (1)

Loading locations...

相似试验