Non Small Cell Lung CancerREGISTURK-LUNGNCT05254119
DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS
An observational study of Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Mahmut Gumus at 39 sites in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- How many people
- 6,000 participants
- Where
- 39 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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"
Who may be able to join
- Patient histopathologically diagnosed with non-small cell lung cancer or small cell lung cancer
- Written informed consent no later than six weeks after start of first-line treatment
- Age ≥ 18 years
Who cannot join
- Volunteers participating in a research program for non-small cell or small cell lung cancer that includes interventions outside of routine clinical trial
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Turkey (Türkiye)39 sites
Adana Başkent University Hospital
Adana
Adana City Training and Research Hospital
Adana
Ankara City Hospital (1)
Ankara
Ankara City Hospital (2)
Ankara
Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
Ankara Gülhane Traning and Research Hospital
Ankara
Ankara Liv Hospital
Ankara
Ankara Memorial Hospital
Ankara
Dıskapı Yıldırım Beyazid Training and Research Hospital
Ankara
Antalya Training and Research Hospital
Antalya
Bursa Uludağ University Hospital
Bursa
Canakkale 18 Mart University Medicine Faculty Hopsital
Çanakkale
Dicle University Medicine Faculty Hospital
Diyarbakır
Trakya University Medicine Faculty Hospital
Edirne
Erzurum Atatürk University Medicine Faculty Hospital
Erzurum
Gaziantep University Medicine Faculty Hospital
Gaziantep
Acibadem University Hospital
Istanbul
Akdeniz University Medicine Faculty Hospital
Istanbul
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
Bezmialem Vakıf University Hospital
Istanbul
Istanbul Medeniyet University
Istanbul
Istanbul Oncology Hospital
Istanbul
Istanbul Umraniye Training and Research Hsopital
Istanbul
Istanbul University Cerrahpasa Medicine Faculty Hospital
Istanbul
Kartal Dr. Lütfi Kırdar Training and Research Hospital
Istanbul
Marmara University Hospital
Istanbul
Medipol University Hospital
Istanbul
Pendik Medical Park Hospital
Istanbul
Prof.Dr. Cemil Taşcıoğlu City Hospital
Istanbul
Sureyyapasa Chest Disease Hospital
Istanbul
Ege University Medicine Fculty Hospital
Izmir
Izmir Medical Park Hospital
Izmir
Kocaeli University Hospital
İzmit
Erciyes Üniversity Medicine Faculty Hospital
Kayseri
Necmettin Erbakan University Meram Medicine Faculty Hospital
Konya
Inonu Uniersity Medicine Faculty Hospital
Malatya
Sakarya University Training and Research Hospital
Sakarya
Samsun Ondokuz Mayıs University Medicine Faculty Hospital
Samsun
Karadeniz Technical University Medicine Faculty Hospital
Trabzon
About this study
Official title: 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
Read the 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.
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of molecular/mutational analysis
To collect data on the frequency of molecular/mutational biomarker testing
Measured: throughout of treatment, 36 months
Type of molecular/mutational analysis
To collect data on the type of molecular/mutational biomarker testing
Measured: throughout of treatment, 36 months
Secondary outcomes (6)
Type of treatment
To describe systemic treatments and sequential treatments applied in real-life practice.
Measured: throughout of treatment, 36 months
The Rate of Response Rate
Response rate
Measured: throughout of treatment, 36 months
Progression free survival time
Progression free survival
Measured: throughout of treatment, 36 months
Overall survival time
Overall survival
Measured: throughout of treatment, 36 months
The frequency of comorbidities
Comorbidities rate
Measured: throughout of treatment, 36 months
Advers events rate
Advers events
Measured: throughout of treatment, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmut Gumus
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Mahmut Gumus, Oncological Clinical Research Association, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254119
- Sponsor's protocol ID
- LUNG-RWD-001
- Acronym
- REGISTURK-LUNG
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGISTRY PLATFORM INTO DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS
- ClinicalTrials.gov ID
- NCT05254119
- Acronym / sponsor ID
- REGISTURK-LUNG / LUNG-RWD-001
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Mahmut GumusResearch network
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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"
Key inclusion criteria (3 listed)
- Patient histopathologically diagnosed with non-small cell lung cancer or small cell lung cancer
- Written informed consent no later than six weeks after start of first-line treatment
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Volunteers participating in a research program for non-small cell or small cell lung cancer that includes interventions outside of routine clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of molecular/mutational analysis
Time frame: throughout of treatment, 36 months
To collect data on the frequency of molecular/mutational biomarker testing
Type of molecular/mutational analysis
Time frame: throughout of treatment, 36 months
To collect data on the type of molecular/mutational biomarker testing
6 secondary outcomes
Type of treatment
Time frame: throughout of treatment, 36 months
The Rate of Response Rate
Time frame: throughout of treatment, 36 months
Progression free survival time
Time frame: throughout of treatment, 36 months
Overall survival time
Time frame: throughout of treatment, 36 months
The frequency of comorbidities
Time frame: throughout of treatment, 36 months
Advers events rate
Time frame: throughout of treatment, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Mahmut Gumus at 39 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of molecular/mutational analysis (time frame: throughout of treatment, 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.