Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Completed

• Conditions: EGFR Gene Mutation; Lung Neoplasms; KRAS Gene Mutation

• Registration Number: NCT03171636
• Lead Sponsor: Hospital Erasto Gaertner

Brief Summary

The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed Description

Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Primary Completion: 2017-09
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Brazilian patients with metastatic non-small cell lung cancer.

Exclusion Criteria

• Small cell lung cancer and non-metastatic patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EGRF mutation status	3 years	results of presence or absence in all tumor samples (FFPE) obtained from patients
KRAS mutation status	3 years	results of presence or absence in all tumor samples (FFPE) obtained from patients

Trial Locations

Locations (1)

Hospital Erasto Gaertner; 🇧🇷 Curitiba, Parana, Brazil