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Trial record 36 of 322 for:    "Adenocarcinoma of lung"

EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA (EGFRdelEx19)

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ClinicalTrials.gov Identifier: NCT02975752
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Filiz Oezkan, University Hospital, Essen

Brief 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).

Condition or disease Intervention/treatment
Lung Adenocarcinoma Metastatic Genetic: LC-RT-PCR and NGS

Detailed 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.


Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. detection of mutations [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
EBUS-TBNA specimen of lymph nodes and primary tumor


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected lung cancer on the chest CT-scan images receiving EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration) for clinical pre-treatment workup of mediastinal and hilar lymph nodes
Criteria

Inclusion Criteria:

  • lung adenocarcinoma positive EBUS-TBNA specimen

Exclusion Criteria:

  • other diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975752


Sponsors and Collaborators
University Hospital, Essen
Investigators
Principal Investigator: Filiz Özkan, MD Department of Interventional Pneumology

Responsible Party: Filiz Oezkan, Dr. med. Filiz Özkan, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT02975752     History of Changes
Other Study ID Numbers: EGFRdelEx 19 KRAS Exon 2
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases