DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS (REGISTURK-LUNG)

April 2, 2024 updated by: Mahmut Gumus

REGISTRY PLATFORM INTO DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS

Observational, prospective clinical research, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Turkey

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

In Turkey, non-small cell lung cancer (NSCLC) is the most common cause of cancer-related death in men and one of the most common causes of cancer-related deaths in women. Because of the heterogeneity of NSCLC or SCLC, it is crucial to characterize the biology of the tumor as exact as possible, to predict the course of disease as accurate as possible, and to determine the optimal therapeutic algorithm as early as possible after initial diagnostic work-up.

These efforts are an obligatory part of the initial diagnostics, since thorough knowledge of the biology of the disease and the resulting therapeutic options ensure optimal care of Volunteers with NSCLC or SCLC. The aim of REGISTURK is to set up a national clinical research platform to document molecular testing, treatment and course of disease of patients with NSCLC or SCLC.

Study Type

Observational

Enrollment (Actual)

6000

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
        • Adana Baskent University Hospital
      • Adana, Turkey
        • Adana City Training and Research Hospital
      • Ankara, Turkey
        • Ankara City Hospital (1)
      • Ankara, Turkey
        • Ankara City Hospital (2)
      • Ankara, Turkey
        • Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara, Turkey
        • Ankara Gülhane Traning and Research Hospital
      • Ankara, Turkey
        • Ankara Liv Hospital
      • Ankara, Turkey
        • Ankara Memorial Hospital
      • Ankara, Turkey
        • Dıskapı Yıldırım Beyazid Training and Research Hospital
      • Antalya, Turkey
        • Antalya Training and Research Hospital
      • Bursa, Turkey
        • Bursa Uludag University Hospital
      • Diyarbakır, Turkey
        • Dicle University Medicine Faculty Hospital
      • Edirne, Turkey
        • Trakya University Medicine Faculty Hospital
      • Erzurum, Turkey
        • Erzurum Atatürk University Medicine Faculty Hospital
      • Gaziantep, Turkey
        • Gaziantep University Medicine Faculty Hospital
      • Istanbul, Turkey
        • Marmara University Hospital
      • Istanbul, Turkey
        • Bakırköy Dr. Sadi Konuk Training and Research Hospital
      • Istanbul, Turkey
        • Istanbul Medeniyet University
      • Istanbul, Turkey
        • Acibadem University Hospital
      • Istanbul, Turkey
        • Akdeniz University Medicine Faculty Hospital
      • Istanbul, Turkey
        • Bezmialem Vakıf University Hospital
      • Istanbul, Turkey
        • Istanbul Oncology Hospital
      • Istanbul, Turkey
        • Istanbul Umraniye Training and Research Hsopital
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa Medicine Faculty Hospital
      • Istanbul, Turkey
        • Kartal Dr. Lütfi Kırdar Training and Research Hospital
      • Istanbul, Turkey
        • Medipol University Hospital
      • Istanbul, Turkey
        • Pendik Medical Park Hospital
      • Istanbul, Turkey
        • Prof.Dr. Cemil Taşcıoğlu City Hospital
      • Istanbul, Turkey
        • Sureyyapasa Chest Disease Hospital
      • Kayseri, Turkey
        • Erciyes Üniversity Medicine Faculty Hospital
      • Konya, Turkey
        • Necmettin Erbakan University Meram Medicine Faculty Hospital
      • Malatya, Turkey
        • Inonu Uniersity Medicine Faculty Hospital
      • Sakarya, Turkey
        • Sakarya University Training and Research Hospital
      • Samsun, Turkey
        • Samsun Ondokuz Mayıs University Medicine Faculty Hospital
      • Trabzon, Turkey
        • Karadeniz Technical University Medicine Faculty Hospital
      • Çanakkale, Turkey
        • Canakkale 18 Mart University Medicine Faculty Hopsital
      • İzmir, Turkey
        • Ege University Medicine Fculty Hospital
      • İzmir, Turkey
        • Izmir Medical Park Hospital
      • İzmit, Turkey
        • Kocaeli University Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Six thousands REGISTURK patients treated at 42 study sites (university hospitals, education and research hospitals and private hospital-based oncology practices).REGISTURK sites will be selected in accordance with patients load, hospital type and geographical distribution. All patients diagnosed with NSCLC or SCLC at selected centers will be enrolled consecutively throughout the study period. All patients diagnosed with lung cancer who receive treatment or who are followed with the best supportive care approach or refuse treatment will be recorded. All approaches in this regard will be determined and the reasons will be examined. Adult male and female patients with non-small cell (early, locally advanced or metastatic) or small cell will be considered "REGISTURK-LUNG patients"

Description

Inclusion Criteria:

  1. Patient histopathologically diagnosed with non-small cell lung cancer or small cell lung cancer
  2. Written informed consent no later than six weeks after start of first-line treatment
  3. Age ≥ 18 years

Exclusion Criteria:

  • Volunteers participating in a research program for non-small cell or small cell lung cancer that includes interventions outside of routine clinical trial

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of molecular/mutational analysis
Time Frame: throughout of treatment, 36 months
To collect data on the frequency of molecular/mutational biomarker testing
throughout of treatment, 36 months
Type of molecular/mutational analysis
Time Frame: throughout of treatment, 36 months
To collect data on the type of molecular/mutational biomarker testing
throughout of treatment, 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of treatment
Time Frame: throughout of treatment, 36 months
To describe systemic treatments and sequential treatments applied in real-life practice.
throughout of treatment, 36 months
The Rate of Response Rate
Time Frame: throughout of treatment, 36 months
Response rate
throughout of treatment, 36 months
Progression free survival time
Time Frame: throughout of treatment, 36 months
Progression free survival
throughout of treatment, 36 months
Overall survival time
Time Frame: throughout of treatment, 36 months
Overall survival
throughout of treatment, 36 months
The frequency of comorbidities
Time Frame: throughout of treatment, 36 months
Comorbidities rate
throughout of treatment, 36 months
Advers events rate
Time Frame: throughout of treatment, 36 months
Advers events
throughout of treatment, 36 months

Collaborators and Investigators

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

Sponsor

Mahmut Gumus

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 (Actual)

December 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUNG-RWD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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