Lung CancerLCRNCT03276429
Lung Cancer Registry for Lung Cancer Patients
An observational study of Lung Cancer, run by Oncology Center of Biochemical Education And Research at 1 site in Greece.
Trial summary
In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 650 participants
- Where
- 1 siteGreece
- Study dates
- 8 Aug 2017to 27 Dec 2018
- 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: All patients with lung cancer that they have been referred to our Unit will be captured to this electronic database
Who may be able to join
- Since this will be a non-interventional study all adult patients who will be consent for registration of their data to EDB will be enrolled.
Who cannot join
- Patients with insufficient epidemiological or clinical data will be excluded such as patients with no demographic data or patients that have not taken at least 2 cycles of therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Electronic Data Base for Lung Cancer Registry Which Will Include All the Epidemiological, Clinical, Pathological, Molecular and Treatment Parameters in Lung Cancer Patients Who Are Referred to a Tertiary Oncology Unit
In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base (EDB).
Read the detailed description
Investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include: a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1) testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and Progression Free Survival (PFS).
- Conditions
- Lung Cancer
- Keywords
- NSCLC, SCLC, MOLECULAR BIOMARKERS
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer patients | All patients with lung cancer that referred to a tertiary Oncology Unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause.
Measured: 12months
Secondary outcomes (2)
Response Rate
Response Rate (RR) is defined as clinical or objective (imaging) response to treatment. Assessments of objective response will be done according to RECIST 1.1.All relevant data (clinical and radiological assessment) will be recorded and reported chronologically and will be correlated with the line and regimen of treatment.
Measured: 12 months
Progression Free Survival
Progression Free Survival (PFS) will be captured for all patients. PFS is defined as the time in months, from the start of the treatment till radiological or clinical progression of the disease or death. PFS will be measured for every line of therapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start8 Aug 2017
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Center of Biochemical Education And Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Konstantinos N Syrigos, MD,PhD, Principal investigator, Non-Governmental, Non-Profit Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276429
- Sponsor's protocol ID
- CA209-9MT
- Acronym
- LCR
- Status last verified
- Mar 2019
- First submitted
- 23 Aug 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Electronic Data Base for Lung Cancer Registry Which Will Include All the Epidemiological, Clinical, Pathological, Molecular and Treatment Parameters in Lung Cancer Patients Who Are Referred to a Tertiary Oncology Unit
- ClinicalTrials.gov ID
- NCT03276429
- Acronym / sponsor ID
- LCR / CA209-9MT
- Conditions
- Lung Cancer
- Keywords
- NSCLC, SCLC, MOLECULAR BIOMARKERS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Oncology Center of Biochemical Education And ResearchUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 8 Sep 2017 (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.
In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base (EDB).
Detailed description
Investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include: a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1) testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and Progression Free Survival (PFS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer patients | – | –All patients with lung cancer that referred to a tertiary Oncology Unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with lung cancer that they have been referred to our Unit will be captured to this electronic database
Key inclusion criteria (1 listed)
- Since this will be a non-interventional study all adult patients who will be consent for registration of their data to EDB will be enrolled.
Key exclusion criteria (1 listed)
- Patients with insufficient epidemiological or clinical data will be excluded such as patients with no demographic data or patients that have not taken at least 2 cycles of therapy.
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
Overall survival (OS)
Time frame: 12months
Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause.
2 secondary outcomes
Response Rate
Time frame: 12 months
Progression Free Survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Konstantinos N Syrigos, MD,PhD principal investigator
Non-Governmental, Non-Profit Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Oncology Center of Biochemical Education And Research at 1 site in Greece.
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 1 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: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (OS) (time frame: 12months). 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 14 Mar 2019.