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Идёт набор NCT06644144

P4O2 ILD Extension

— Наблюдательное Interstitial Lung Disease Pulmonary Fibrosis Interstitial Lung Fibrosis IPF

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Interventions.
Кому может быть актуально
Состояния в реестре: Interstitial Lung Disease, Pulmonary Fibrosis, Interstitial Lung Fibrosis, IPF. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
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Официальное название

Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.

Обзор

The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in participants with interstitial lung diseases (ILDs). The participant population includes adults diagnosed with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic ILDs, and interstitial lung abnormalities (ILA). The main questions it aims to answer are: * What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients? * What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD? * What biomarkers and risk factors can help identify ILA patients who may develop significant ILD? * What biomarkers and risk factors can predict how well ILD patients will respond to treatment? Researchers will compare the outcomes between participants diagnosed with IPF/FPF, other fibrotic ILDs, and ILA to see if early detection biomarkers differ among these groups. Participants will: * Undergo blood sampling. * Perform lung function tests. * Have CT scans. * Perform breath analysis * Participate in exposome and microbiome analyses. * Complete questionnaires. * A subgroup of participants will be offered bronchoscopy.

Подробное описание

Included participants will complete several study visits to collect clinical data and biological samples. Study visits will be performed at baseline, 3, 6, 12, 24, 36, 48 and 60 months, with a 2-month time window for follow-up visits. These time points are aligned with the standard clinical follow-up visits outlined in the ILD Care Path Protocol of Amsterdam UMC.

Вмешательства

  • Другое No Interventions
    No intervention so not applicable.

Первичные конечные точки

  • Inflammatory and fibrosis extent assessed by HRCT [Срок оценки: A baseline HRCT scan will be performed during screening. Following inclusion in the study, HRCT scans will be repeated annually, starting one year after the initial scan, and continuing each year until the end of follow-up (at 5 years))]
  • Pulmonary function tests (PFTs)- Spirometry volumes [Срок оценки: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Pulmonary function tests (PFTs)- DLCO measurement [Срок оценки: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Pulmonary function tests (PFTs)- Lungvolume measurement [Срок оценки: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Biomarkers related to pulmonary fibrosis will be measured in plasma and serum [Срок оценки: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Peripheral blood mononuclear cell (PBMC) populations in blood [Срок оценки: It will be measured Will be measured at baseline, at 3, 6 months, 12 months, and every other year till end of follow-up (60months)]
  • Exhaled breath analysis including volatile organic compounds [Срок оценки: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
Вторичные конечные точки (12)
  • Disease-relevant questionnaires: Exposure Questionnaire [Срок оценки: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: KBILD questionnaire. [Срок оценки: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Modified Medical Research Council Dyspnea score [Срок оценки: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Visual analog scale (VAS) [Срок оценки: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Fatigue Severity Scale (FSS) [Срок оценки: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Genomics analysis in blood. [Срок оценки: Genomics are done once at baseline.]
  • Epigenomics analysis in blood. [Срок оценки: Epigonomics are done at baseline and 1 year after inclusion.]
  • Transcriptome analysis in blood. [Срок оценки: Transcriptome is performed at baseline, 6 months and 1 year after inclusion.]
  • Proteome analysis in bronchoalveolar lavage fluid [Срок оценки: In Group 3, thirty participants will undergo bronchoalveolar lavage at baseline. Additional procedures may be performed during the follow-up period if clinically indicated and will be added to samples. .]
  • Microbiome analyses in stool and nasal swabs. [Срок оценки: Once in first year]
  • Concentration of Biomarkers in Exhaled Particles (Collected via Impaction) [Срок оценки: From moment of inclusion every year untill end of follow-up at 60 months.]
  • Identification of Compounds in Exhaled Particles via Mass Spectrometry (MS) [Срок оценки: From moment of inclusion every year untill end of follow-up at 60 months.]

Критерии участия

Критерии включения

  • Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).
  • Meeting all the following criteria during the screening period:
  • FVC ≥45% predicted.
  • FEV1/FVC ≥0.7.
  • DLco corrected for Hb ≥40% predicted.
  • Able to provide written informed consent as approved by the independent ethics committee.
  • Able to undergo a CT scan and perform PFT.
  • Age \> 18 years and \< 80 years.
  • Understanding of the Dutch or English language.

Критерии исключения

  • Combined pulmonary fibrosis and emphysema (CPFE) diagnosis
  • Chronic obstructive lung disease (COPD) with an FEV1/FVC \<70%.
  • Uncontrolled severe asthma.
  • Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.
  • Pregnancy or lactating.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Amsterdam UMC, locatie VUmc — Amsterdam

Идентификаторы

NCT: NCT06644144 · 2023.0591 · NL84006.018.23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗