Clinical trial NCT05254119: DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS
Official title: REGISTRY PLATFORM INTO DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non Small Cell Lung Cancer
Small-cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Immunotherapy
Progression free Survival
Survival
Lead sponsor: Oncological Clinical Research Association, Turkey
Sponsor class: NETWORK
First posted: 2022-02-24
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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"

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of molecular/mutational analysis
timeFrame: throughout of treatment, 36 months
measure: Type of molecular/mutational analysis
timeFrame: throughout of treatment, 36 months
Secondary outcomes:
measure: Type of treatment
timeFrame: throughout of treatment, 36 months
measure: The Rate of Response Rate
timeFrame: throughout of treatment, 36 months
measure: Progression free survival time
timeFrame: throughout of treatment, 36 months
measure: Overall survival time
timeFrame: throughout of treatment, 36 months
measure: The frequency of comorbidities
timeFrame: throughout of treatment, 36 months
measure: Advers events rate
timeFrame: throughout of treatment, 36 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Başkent University Hospital
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital (1)
city: Ankara
country: Turkey
facility: Ankara City Hospital (2)
city: Ankara
country: Turkey
facility: Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Gülhane Traning and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Liv Hospital
city: Ankara
country: Turkey
facility: Ankara Memorial Hospital
city: Ankara
country: Turkey
facility: Dıskapı Yıldırım Beyazid Training and Research Hospital
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
city: Bursa
country: Turkey
facility: Bursa Uludağ University Hospital
city: Diyarbakır
country: Turkey
facility: Dicle University Medicine Faculty Hospital
city: Edirne
country: Turkey
facility: Trakya University Medicine Faculty Hospital
city: Erzurum
country: Turkey
facility: Erzurum Atatürk University Medicine Faculty Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University Medicine Faculty Hospital
city: Istanbul
country: Turkey
facility: Acibadem University Hospital
city: Istanbul
country: Turkey
facility: Akdeniz University Medicine Faculty Hospital
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
city: Istanbul
country: Turkey
facility: Istanbul Oncology Hospital
city: Istanbul
country: Turkey
facility: Istanbul Umraniye Training and Research Hsopital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medicine Faculty Hospital
city: Istanbul
country: Turkey
facility: Kartal Dr. Lütfi Kırdar Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Hospital
city: Istanbul
country: Turkey
facility: Medipol University Hospital
city: Istanbul
country: Turkey
facility: Pendik Medical Park Hospital
city: Istanbul
country: Turkey
facility: Prof.Dr. Cemil Taşcıoğlu City Hospital
city: Istanbul
country: Turkey
facility: Sureyyapasa Chest Disease Hospital
city: İzmir
country: Turkey
facility: Ege University Medicine Fculty Hospital
city: İzmir
country: Turkey
facility: Izmir Medical Park Hospital
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
city: Kayseri
country: Turkey
facility: Erciyes Üniversity Medicine Faculty Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medicine Faculty Hospital
city: Malatya
country: Turkey
facility: Inonu Uniersity Medicine Faculty Hospital
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
city: Samsun
country: Turkey
facility: Samsun Ondokuz Mayıs University Medicine Faculty Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medicine Faculty Hospital
city: Çanakkale
country: Turkey
facility: Canakkale 18 Mart University Medicine Faculty Hopsital
Study officials:
References: