EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Lung Adenocarcinoma Metastatic Clinical Trial

— EGFRdelEx19  

Official title:

Rapid and Highly Sensitive EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA Specimen of Lymph Node Metastases From Patients With Lung Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975752
• Other study ID #: EGFRdelEx 19 KRAS Exon 2
• Status: Completed
• Phase: N/A
• First received: November 23, 2016
• Last updated: November 23, 2016
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Description:

First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• lung adenocarcinoma positive EBUS-TBNA specimen

Exclusion Criteria:

• other diagnosis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma Metastatic
• Lung Neoplasms

Intervention

Genetic:
• LC-RT-PCR and NGS
highly sensitive PCR vs. multiplex targeted-resequencing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of mutations		1 year	No