Research of Burden of Interstititial Lung Diseases in Turkey

Lung Diseases, Interstitial Clinical Trial

— RBILD  

Official title:

Research of Burden of Interstititial Lung Diseases in Turkey

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03995654
• Other study ID #: 2018/176
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fibrosis Lung
• Lung Diseases
• Lung Diseases, Interstitial

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