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

Sponsor
Hospital Erasto Gaertner (Other)
Overall Status
Completed
CT.gov ID
NCT03171636
Collaborator
AstraZeneca (Industry)
130
Enrollment
1
Location
57
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official 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.
    Actual Study Start Date :
    Apr 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2017
    Actual Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. EGRF mutation status [3 years]

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

    2. KRAS mutation status [3 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Brazilian patients with metastatic non-small cell lung cancer.
    Exclusion Criteria:
    • Small cell lung cancer and non-metastatic patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Erasto Gaertner Curitiba Parana Brazil 81520-060

    Sponsors and Collaborators

    • Hospital Erasto Gaertner
    • AstraZeneca

    Investigators

    • Principal Investigator: Thais A Almeida, MD, Liga Paranaense de Combate ao Cancer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thais Abreu de Almeira, MD, Hospital Erasto Gaertner
    ClinicalTrials.gov Identifier:
    NCT03171636
    Other Study ID Numbers:
    • HEG02
    First Posted:
    May 31, 2017
    Last Update Posted:
    Feb 22, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Feb 22, 2019