DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; Small-cell Lung Cancer

• Registration Number: NCT05254119
• Lead Sponsor: Mahmut Gumus

Brief Summary

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

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 Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of molecular/mutational analysis	throughout of treatment, 36 months	To collect data on the frequency of molecular/mutational biomarker testing
Type of molecular/mutational analysis	throughout of treatment, 36 months	To collect data on the type of molecular/mutational biomarker testing

Secondary Outcome Measures

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

Trial Locations

Locations (39)

Adana Başkent University Hospital; 🇹🇷 Adana, Turkey

Adana City Training and Research Hospital; 🇹🇷 Adana, 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; 🇹🇷 Ankara, Turkey

Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey

Dicle University Medicine Faculty Hospital; 🇹🇷 Diyarbakır, Turkey

Trakya University Medicine Faculty Hospital; 🇹🇷 Edirne, Turkey

Gaziantep University Medicine Faculty Hospital; 🇹🇷 Gaziantep, Turkey

Bakırköy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Bezmialem Vakıf University Hospital; 🇹🇷 Istanbul, Turkey

Istanbul Oncology Hospital; 🇹🇷 Istanbul, Turkey

Istanbul University Cerrahpasa Medicine Faculty Hospital; 🇹🇷 Istanbul, Turkey

Kocaeli University Hospital; 🇹🇷 İzmit, Turkey

Karadeniz Technical University Medicine Faculty Hospital; 🇹🇷 Trabzon, Turkey

Medipol University Hospital; 🇹🇷 Istanbul, Turkey

Pendik Medical Park Hospital; 🇹🇷 Istanbul, Turkey

Prof.Dr. Cemil Taşcıoğlu City Hospital; 🇹🇷 Istanbul, Turkey

Inonu Uniersity Medicine Faculty Hospital; 🇹🇷 Malatya, Turkey

Samsun Ondokuz Mayıs University Medicine Faculty Hospital; 🇹🇷 Samsun, Turkey

Bursa Uludağ University Hospital; 🇹🇷 Bursa, Turkey

Erzurum Atatürk University Medicine Faculty Hospital; 🇹🇷 Erzurum, Turkey

Acibadem University Hospital; 🇹🇷 Istanbul, Turkey

Akdeniz University Medicine Faculty Hospital; 🇹🇷 Istanbul, Turkey

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey

Istanbul Umraniye Training and Research Hsopital; 🇹🇷 Istanbul, Turkey

Sureyyapasa Chest Disease Hospital; 🇹🇷 Istanbul, Turkey

Ege University Medicine Fculty Hospital; 🇹🇷 İzmir, Turkey

Izmir Medical Park Hospital; 🇹🇷 İzmir, Turkey

Sakarya University Training and Research Hospital; 🇹🇷 Sakarya, Turkey

Canakkale 18 Mart University Medicine Faculty Hopsital; 🇹🇷 Çanakkale, Turkey

Ankara City Hospital (1); 🇹🇷 Ankara, Turkey

Ankara City Hospital (2); 🇹🇷 Ankara, Turkey

Marmara University Hospital; 🇹🇷 Istanbul, Turkey

Erciyes Üniversity Medicine Faculty Hospital; 🇹🇷 Kayseri, Turkey

Kartal Dr. Lütfi Kırdar Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Necmettin Erbakan University Meram Medicine Faculty Hospital; 🇹🇷 Konya, Turkey