Lung Cancer Registry for Lung Cancer Patients

Completed

• Conditions: Lung Cancer

• Registration Number: NCT03276429
• Lead Sponsor: Oncology Center of Biochemical Education And Research

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).

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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.

Secondary Outcome Measures

Name	Time	Method
Response Rate	12 months	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.
Progression Free Survival	12 months	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.

Trial Locations

Locations (1)

OCEBER; 🇬🇷 Athens, Greece