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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03995654
Other study ID # 2018/176
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2021

Study information

Verified date March 2021
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of our study is to investigate the etiological distribution of ILD, epidemiological characteristics of ILD cases such as age, gender, geography, smoking, occupation, economic status, education, and comorbidities. Another aim is to make the cost calculation from the first to the diagnosis in the patients diagnosed. Obtaining the missing data related to the ILD of our country is one of our goals.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date May 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients who are not previously diagnosed with ILD will be included in the study. Exclusion Criteria: - under 18 years old - older 80 years old

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Department Of Chest Diseases, School Of medicine, Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Etiological distribution The aim of our study is to investigate the etiological distribution of ILD 1 year
Primary Etiological distribution Geographic distribution of ILD patients according to regions (will be presented as %) 1 year
Primary Epidemiological characteristics of ILD cases Age (years) 1 year
Primary Epidemiological characteristics of ILD cases Gender (male, female; (will be presented as %)) 1 year
Primary Epidemiological characteristics of ILD cases Smoking (yes, no; (will be presented as %) 1 year
Primary Epidemiological characteristics of ILD cases Distribution of ILD patients according to the occupation (will be presented as %) 1 year
Primary Epidemiological characteristics of ILD cases Economic status (monthly salary of patients according to ILD types and stages of ILD) 1 year
Primary Epidemiological characteristics of ILD cases Distiribution of ILD patienst according to comorbidities (will be presented as YES or NO and %) Comorbiditites are; Hypertension, Heart failure, Coronary Artery Disease, Arrhythmia, Heart Valve Disease, Asthma, COPD, Chronic Renal Disease, Diabetes Mellitus, Hyper / Hypothyroidism, HIV, Cirrhosis / Chronic Liver Disease, Lung malignancy, Extrapulmonary solid organ malignancy, Hematologic malignancy, SVO, Alzeimer, Epilepsy, Neuromuscular Ill, Organ Transplant Receiver, Reflux, Slyding hernia, Others 1 year
Primary Total number We planned enroll roughly 1000 patients to the study 1 year
Secondary Clinical findings According to the etiology of ILD, clinical findings (Rod, Ral, Rash, Arthritis, Alopecia, Erythema nodosum, Peripheral lymphadenomegaly, Cyanosis, Edema, Raynaud's phenomenon, Other) will be presented as YES or NO and % 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; FVC (ml) and (%pred) 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; FEV 1 (ml) and (%pred) 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; DLCO (mL.min.mmHg) and (%pred) 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; DLCO/VA (mL.min.mmHg) and (%pred) 6dk YT (meters) Pulseoksimetre ile PaO2 (%) 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; 6min Walk Test (meters) 1year
Secondary Pulmonary functions According to the etiology of ILD, pulmonary functions, will be assessed; PaO2 with Pulse oximeter (%) 1year
Secondary Diagnostic methods According to the etiology of ILD, diagnostic methods used in ILD cases will be presented Diagnoses methods are; Clinical and radiology, Bronchoscopic transbronchial lung biopsy, Bronchoalveolar lavage, Transthoracic needle biopsy with imaging, EBUS, VATS, Thoracotomy, Other (Methods are will be shown as YES or NO and %) 1year
Secondary Time According to the etiology of ILD, the time spent for diagnosis will be presented Time will be presented as months. 1year
Secondary Treatment methods Determining the treatment preferences of physicians according to the etiology of the cases will be presented; Treatment methods are; Non-treatment monitoring, Symptomatic treatment, Systemic corticosteroid, Cytostatic drugs, Antifibrosan drugs (eg Pirfenidone, Nintedanib), Immunological therapy, Referral to other centers, Preparing for transplantation, Home oxygen therapy, Reflux therapy, Other (Methods are will be shown as YES or NO and %) 1year
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