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Lung Diseases, InterstitialRBILDNCT03995654

Research of Burden of Interstititial Lung Diseases in Turkey

An observational study of Lung Diseases, Interstitial and Fibrosis Lung, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Diseases, Interstitial, Fibrosis Lung
How many people
1,000 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2019to 1 May 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will be a multicenter prospective cross-sectional study in Turkey, that will be the coordinating center of our Department of Chest Diseases

Who may be able to join

  • Patients who are not previously diagnosed with ILD will be included in the study.

Who cannot join

  • under 18 years old
  • older 80 years old

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Department Of Chest Diseases, School Of medicine, Karadeniz Technical University

    Trabzon, 61080

Other trials in Turkey (Türkiye)

About this study

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.

Keywords
Interstitial Lung Diseases, Fibrotic Lung, Prevalence
Medical subject headings
Lung Diseases, Interstitial, Pulmonary Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Etiological distribution

    The aim of our study is to investigate the etiological distribution of ILD

    Measured: 1 year

  2. Etiological distribution

    Geographic distribution of ILD patients according to regions (will be presented as %)

    Measured: 1 year

  3. Epidemiological characteristics of ILD cases

    Age (years)

    Measured: 1 year

  4. Epidemiological characteristics of ILD cases

    Gender (male, female; (will be presented as %))

    Measured: 1 year

  5. Epidemiological characteristics of ILD cases

    Smoking (yes, no; (will be presented as %)

    Measured: 1 year

  6. Epidemiological characteristics of ILD cases

    Distribution of ILD patients according to the occupation (will be presented as %)

    Measured: 1 year

  7. Epidemiological characteristics of ILD cases

    Economic status (monthly salary of patients according to ILD types and stages of ILD)

    Measured: 1 year

  8. 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

    Measured: 1 year

  9. Total number

    We planned enroll roughly 1000 patients to the study

    Measured: 1 year

Secondary outcomes (10)

  1. 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 %

    Measured: 1year

  2. Pulmonary functions

    According to the etiology of ILD, pulmonary functions, will be assessed; FVC (ml) and (%pred)

    Measured: 1year

  3. Pulmonary functions

    According to the etiology of ILD, pulmonary functions, will be assessed; FEV 1 (ml) and (%pred)

    Measured: 1year

  4. Pulmonary functions

    According to the etiology of ILD, pulmonary functions, will be assessed; DLCO (mL.min.mmHg) and (%pred)

    Measured: 1year

  5. 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 (%)

    Measured: 1year

  6. Pulmonary functions

    According to the etiology of ILD, pulmonary functions, will be assessed; 6min Walk Test (meters)

    Measured: 1year

  7. Pulmonary functions

    According to the etiology of ILD, pulmonary functions, will be assessed; PaO2 with Pulse oximeter (%)

    Measured: 1year

  8. 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 %)

    Measured: 1year

  9. Time

    According to the etiology of ILD, the time spent for diagnosis will be presented Time will be presented as months.

    Measured: 1year

  10. 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 %)

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Apr 2021 (estimated)
  4. Study completion1 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995654
Sponsor's protocol ID
2018/176
Acronym
RBILD
Status last verified
Mar 2021
First submitted
30 May 2019
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to ethical approve, IPD will not be shared with other researchers unless after ethical approves for any further study, researchers can ask for data

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, Interstitial and Fibrosis Lung, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Etiological distribution (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

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