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Completed

NCT Number: NCT03171636

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

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.

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Key information

Conditions

Lung Neoplasms EGFR Gene Mutation KRAS Gene Mutation Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Small cell lung cancer and non-metastatic patients.

Treatment and study plan

Primary outcomes

  1. EGRF mutation status

    Time frame: 3 years

    results of presence or absence in all tumor samples (FFPE) obtained from patients

  2. KRAS mutation status

    Time frame: 3 years

    results of presence or absence in all tumor samples (FFPE) obtained from patients

Sponsors and collaborators

Lead sponsor

Hospital Erasto Gaertner

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Analysis of the Types and Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients at Erasto Gaertner Hospital, Curitiba, Brazil.

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
May 31, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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