Clinical trial NCT03951233: K-RAS and EGFR in Lung Cancer
Official title: Genotyping K-RAS and EGFR in Greek Non-small-cell Lung Cancer Patients: Incidence, Significance and Treatment Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 424
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: Patients treated within HeCOG-affiliated centres from March 2000 through December 2012.

Brief summary: Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Detailed description: A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed NSCLC
* Signed and dated written informed consent
* Age 18 years
* Available cytological material

Exclusion Criteria: -

Primary outcomes:
measure: Progression free survival
timeFrame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 9 months
measure: Overall survival
timeFrame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Néo Fáliro
country: Greece
facility: Oncology Unit, Metropolitan Hospital
state: Athens
Study officials:
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