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

NCT ID: NCT03171636

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Lung Neoplasms KRAS Gene Mutation EGFR Gene Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Small cell lung cancer and non-metastatic patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Hospital Erasto Gaertner

OTHER

Sponsor Role lead

Responsible Party

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Thais Abreu de Almeira

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thais A Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

Liga Paranaense de Combate ao Cancer

Locations

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Hospital Erasto Gaertner

Curitiba, ParanĂ¡, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HEG02

Identifier Type: -

Identifier Source: org_study_id

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