Clinical trial NCT03276429: Lung Cancer Registry for Lung Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: NSCLC
SCLC
MOLECULAR BIOMARKERS
Lead sponsor: Oncology Center of Biochemical Education And Research
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-09-08
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with lung cancer that they have been referred to our Unit will be captured to this electronic database

Brief 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 (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).

Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 12months
Secondary outcomes:
measure: Response Rate
timeFrame: 12 months
measure: Progression Free Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: OCEBER
Study officials:
affiliation: Non-Governmental, Non-Profit Organization
name: Konstantinos N Syrigos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: