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Report for Clinical Trial NCT03870828
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Interstitial pneumonia with autoimmune features (IPAF) was defined in 2015 by the Working
Group of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) as
interstitial pneumonia with some clinical and/or serological features suggesting presence of
an underlying autoimmune disorder. However, ofiicial criteria for diagnosis of an autoimmune
disease are not met.
Aims of the study:
1. Determine the incindence of IPAF in comparison with interstitial lung diseases (ILDs)
and classic autoimmune diseases (ADs) in polish pulmonological centers.
2. Clinical, serological, functional and radiological and histopathological characteristics
of IPAF patients.
3. Analysis of diagnostic strategies towards specific IPAF subgroups.
4. Characterictics of potencial diagnostic, predictive and prognostic features of IPAF.
5. Prospective assessment of IPAF patients in the courseof 5 years in order to determine
stability of the diagnosis and potential progression to other diseases, e.g. ADs.
Name: Bronchoalveolar lavage and taking bronchial mucosa samples
Description: Regional anesthesia and sedation with use of lidocaine and midazolam will be performed, according to anesthesia protocols applied in respective endoscopy units. Intravenous cannula will be inserted prior to BF. During endoscopy, the patient will be monitored according to safety protocols applied in respective endoscopy units.
Bronchoalveolar lavage will be performed in the bronchus from the middle robe of right lung or the lingula of left lung (B4, B5). Localization will be chosen based on HRCT results and will be recorded in patient's medical history. Sterile solution of 0, 9% NaCl will be instilled. 200 ml fluid will be applied with a syringe in portions of 25 ml or 50 ml. It is recommended that minimum 60 % of the lavage fluid is retrieved.
Type: Diagnostic Test
Group Labels: 3 Control group CTD-ILD Control group ILD Study group IPAF
Name: 6minute walk test
Description: a submaximal exercise test which entails measurement of distance walked over a span of 6 minutes. Blood pressure, pulse oximetry are measured directly before and after the test. The participant is also periodically asked about their dyspnea sensation
Type: Diagnostic Test
Group Labels: 3 Control group CTD-ILD Control group ILD Study group IPAF
Name: Arterial blood gas
Description: If SpO2 is measured to be < 92%, an artery (radial or femoral) is punctured in order to take a sample of arterial blood. Then, the artery is compressed in order to prevent bleeding/ hematoma.
Type: Diagnostic Test
Group Labels: 3 Control group CTD-ILD Control group ILD Study group IPAF
Name: Blood drawing
Description: A vein will be punctured in order to take a blood sample for further tests
Type: Procedure
Group Labels: 3 Control group CTD-ILD Control group ILD Study group IPAF
Primary Outcomes
Description: It is still unclear whether there are diagnostic markers specific for IPAF or whether there is a significant difference in concentration of fibrosis biomarkers in IPAF, CTD-ILD and ILD groups. Both blood and BAL biomarkers will be taken under consideration, they include chemokine C-C motif ligand 18 (CXCL18), Surfactant Protein A- (SP-A), Surfactant Protein D (SP-D), Krebs von den Lungen-6 protein (KL-6) and chitotrisidase 1 (CHIT1).
Measure: Identification of IPAF diagnostic markers
Time: 10.2019-10.2020
Time Perspective: Prospective
Cohort
There is one SNP
SNPs
1 S1009A
Samples will be checked for concentration of S1009A protein,
chemokine (C-C motif) ligand 2 and chitotrisidase 1 (CHIT 1). --- S1009A ---