DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS

Non Small Cell Lung Cancer Clinical Trial

— REGISTURK-LUNG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05254119
• Other study ID #: LUNG-RWD-001
• Status: Active, not recruiting
• Start date: December 1, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Oncological Clinical Research Association, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Locations

Country	Name	City	State
Turkey	Adana Baskent University Hospital	Adana
Turkey	Adana City Training and Research Hospital	Adana
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	Diskapi Yildirim Beyazid Training and Research Hospital	Ankara
Turkey	Antalya Training and Research Hospital	Antalya
Turkey	Bursa Uludag University Hospital	Bursa
Turkey	Canakkale 18 Mart University Medicine Faculty Hopsital	Çanakkale
Turkey	Dicle University Medicine Faculty Hospital	Diyarbakir
Turkey	Trakya University Medicine Faculty Hospital	Edirne
Turkey	Erzurum Atatürk University Medicine Faculty Hospital	Erzurum
Turkey	Gaziantep University Medicine Faculty Hospital	Gaziantep
Turkey	Acibadem University Hospital	Istanbul
Turkey	Akdeniz University Medicine Faculty Hospital	Istanbul
Turkey	Bakirköy Dr. Sadi Konuk Training and Research Hospital	Istanbul
Turkey	Bezmialem Vakif University Hospital	Istanbul
Turkey	Istanbul Medeniyet University	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 Kirdar Training and Research Hospital	Istanbul
Turkey	Marmara University Hospital	Istanbul
Turkey	Medipol University Hospital	Istanbul
Turkey	Pendik Medical Park Hospital	Istanbul
Turkey	Prof.Dr. Cemil Tascioglu City Hospital	Istanbul
Turkey	Sureyyapasa Chest Disease Hospital	Istanbul
Turkey	Ege University Medicine Fculty Hospital	Izmir
Turkey	Izmir Medical Park Hospital	Izmir
Turkey	Kocaeli University Hospital	Izmit
Turkey	Erciyes Üniversity Medicine Faculty Hospital	Kayseri
Turkey	Necmettin Erbakan University Meram Medicine Faculty Hospital	Konya
Turkey	Inonu Uniersity Medicine Faculty Hospital	Malatya
Turkey	Sakarya University Training and Research Hospital	Sakarya
Turkey	Samsun Ondokuz Mayis University Medicine Faculty Hospital	Samsun
Turkey	Karadeniz Technical University Medicine Faculty Hospital	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Mahmut Gumus

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of molecular/mutational analysis	To collect data on the frequency of molecular/mutational biomarker testing	throughout of treatment, 36 months
Primary	Type of molecular/mutational analysis	To collect data on the type of molecular/mutational biomarker testing	throughout of treatment, 36 months
Secondary	Type of treatment	To describe systemic treatments and sequential treatments applied in real-life practice.	throughout of treatment, 36 months
Secondary	The Rate of Response Rate	Response rate	throughout of treatment, 36 months
Secondary	Progression free survival time	Progression free survival	throughout of treatment, 36 months
Secondary	Overall survival time	Overall survival	throughout of treatment, 36 months
Secondary	The frequency of comorbidities	Comorbidities rate	throughout of treatment, 36 months
Secondary	Advers events rate	Advers events	throughout of treatment, 36 months