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

Lung Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171636
• Other study ID #: HEG02
• Status: Completed
• Start date: April 2014
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: Hospital Erasto Gaertner
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Small cell lung cancer and non-metastatic patients.

Related Conditions & MeSH terms

• EGFR Gene Mutation
• KRAS Gene Mutation
• Lung Neoplasms

Locations

Country	Name	City	State
Brazil	Hospital Erasto Gaertner	Curitiba	Parana

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Erasto Gaertner	AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGRF mutation status	results of presence or absence in all tumor samples (FFPE) obtained from patients	3 years
Primary	KRAS mutation status	results of presence or absence in all tumor samples (FFPE) obtained from patients	3 years