Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study (TURK-UIP)

September 23, 2019 updated by: Turkish Thoracic Society
The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a collaborative project to coordinate a team of investigators from various regions of Turkey. The purpose of the Registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of UIP, and to obtain information about the natural course of the disease and the treatment response.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The TURK-UIP Registry is a web based application that will store information about patients. A HRCT pattern consistent with UIP will be confirmed by 3 radiologists. At the 3-month visits, the pulmonary function tests and the 6-minute walk test will be recorded. Patients will be prospectively followed for a 5-year period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1678

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Cukurova University Medical Faculty
      • Adapazari, Turkey
        • Sakarya University Faculty of Medicine
      • Ankara, Turkey, MD
        • Gazi University Medical Faculty
      • Ankara, Turkey
        • Ankara University Faculty of Medicine
      • Ankara, Turkey
        • Ankara University Medical Faculty
      • Ankara, Turkey
        • Ataturk Chest Diseases and Chest Surgery Education and Research Hospital
      • Ankara, Turkey
        • Atatürk Chest Disease and Chest Surgery Research and Training Hospital
      • Ankara, Turkey
        • Dışkapı Yıldırım Beyazıt training and research hospital
      • Ankara, Turkey
        • Gazi University Medical Faculty
      • Antalya, Turkey
        • Akdeniz University Medical Faculty
      • Aydin, Turkey
        • Adnan Menderes University Faculty of Medicine
      • Bursa, Turkey
        • Uludag University Medical Faculty
      • Denizli, Turkey
        • Pamukkale University Medical Faculty
      • Diyarbakir, Turkey
        • Dicle University Medical Faculty
      • Diyarbakir, Turkey
        • Memorial Diyarbakir Hospital
      • Duzce, Turkey
        • Duzce University Medical Faculty
      • Edirne, Turkey
        • Trakya University Faculty of Medicine
      • Erzurum, Turkey
        • Atatürk University Faculty of Medicine
      • Erzurum, Turkey
        • Ataturk University Medical Faculty
      • Istanbul, Turkey
        • Dr.Lutfi Kirdar Kartal Education and Research Hospital
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey
        • Istanbul University Istanbul Medical Faculty
      • Istanbul, Turkey
        • Istanbul University, Istanbul Medical Faculty
      • Istanbul, Turkey
        • Koc University Medical Faculty
      • Istanbul, Turkey
        • Sisli Florence Nightingale Hospital
      • Istanbul, Turkey
        • Sureyyapasa Chest Diseases and Thoracic Surgery Education and Research Hospital
      • Istanbul, Turkey
        • Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
      • Istanbul, Turkey
        • Süreyyapasa Pulmonary Diseases and Thoracic Surgery Education and Research Hospital
      • Istanbul, Turkey
        • Yedikule Chest Disease Education and Research Hospital
      • Istanbul, Turkey
        • Yedikule Chest Diseases and Chest Surgery Education and Research Hospital
      • Istanbul, Turkey
        • Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
      • Istanbul, Turkey
        • Yedikule Chest Diseases Education and Research Hospital
      • Istanbul, Turkey
        • Yedikule Hospital for Chest Disease and Chest Surgery
      • Istanbul, Turkey
        • Yedikule Hospital for Chest Disease and Thoracic Surgery
      • Istanbul, Turkey
        • Yedikule Pulmonary Diseases Education and Research Hospital
      • Izmir, Turkey
        • Dokuz Eylul University Medical Faculty
      • Izmir, Turkey
        • Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
      • Izmir, Turkey
        • Dr. Suat Seren Pulmonary Diseases and Thoracic Surgery Training and Research Hospital
      • Izmir, Turkey
        • Ege University Faculty of Medicine
      • Izmir, Turkey
        • Ege University Medical Faculty
      • Kirikkale, Turkey
        • Kirikkale University Medical Faculty
      • Kocaeli, Turkey
        • Kocaeli University Faculty of Medicine
      • Kocaeli, Turkey
        • Kocaeli University Medical Faculty
      • Konya, Turkey
        • Necmettin Erbakan University Meram Medical Faculty
      • Samsun, Turkey
        • Ondokuz Mayis University Medical Faculty
      • Trabzon, Turkey
        • Karadeniz Technical University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with IPF and other causes of UIP.

Description

Inclusion Criteria:

  1. Understand and sign the informed consent document.
  2. The presence of a definite or possible UIP pattern on high resolution computed tomography (HRCT) or a histologic UIP pattern (definite, probable and possible) on surgical lung biopsy (as defined by ATS/ERS/JRS/ALAT criteria).

Exclusion Criteria:

  1. HRCT findings inconsistent with UIP pattern (peribronchovascular predominance, extensive ground glass abnormality,profuse micronodules, discrete cysts , consolidation in bronchopulmonary segment(s)/lobe(s), diffuse mosaic attenuation/air-trapping),
  2. Histopathological findings inconsistent with UIP pattern (as defined by ATS/ERS/JRS/ALAT criteria).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of subjects enrolled with IPF and other causes of UIP
Time Frame: 5 years
Natural history of course of disease in patients with IPF and other causes of UIP.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turkish Thoracic Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benan Müsellim, MD, Istanbul University,Cerrahpasa Medical Faculty, Istanbul, Turkey.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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