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Clinical Trials/NCT03276429
NCT03276429
Completed
Not Applicable

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

Oncology Center of Biochemical Education And Research1 site in 1 country650 target enrollmentAugust 8, 2017
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Oncology Center of Biochemical Education And Research
Enrollment
650
Locations
1
Primary Endpoint
Overall survival (OS)
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 8, 2017
End Date
December 27, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oncology Center of Biochemical Education And Research
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Response Rate(12 months)
  • Progression Free Survival(12 months)

Study Sites (1)

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