One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples

A Molecular Test for Rapid On-site Evaluation in EBUS-TBNAsamples of Lung Cancer Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02157857

Enrollment

100

Registered

2014-06-06

Start date

2014-02-28

Completion date

2014-07-31

Last updated

2014-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

NSCLC, SCLC, lung cancer, EBUS-TBNA

Brief summary

The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.

Detailed description

Regional lymph nodes are assessed before tumor resection and before initiation of chemo- or radiotherapy. Endobronchial ultrasound-guided needle aspiration (EBUS-TBNA) is a well-established method for mediastinal and hilar lymph node staging \[2, 3\]. Samples obtained via this route are much smaller than surgical lymph node biopsies, yet they are able to provide complete and thorough evaluation, this includes current molecular testing. One Step Nucleic Acid Amplification (OSNA), a molecular test that utilizes CK 19 mRNA-concentration as a target marker is becoming a rapidly dynamic method in quick detection of sentinel lymph node (SLN) metastases in breast cancer, colon cancer and other cancers. In lung cancer, the role of SLN is not well established. However, recent publications suggest an accurate and rapid detection of lymph node metastases in NSCLC. However this requires complete lymph node dissection either with mediastinoscopy or by other surgical means such as thoracotomy. The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* CT-scan suspicious for lung cancer, * enlarged mediastinal lymph nodes (\>10 mm), * EBUS-TBNA to be performed, * age: 18-99 years

Exclusion criteria

* age: \<18 years

Design outcomes

Primary

Measure	Time frame	Description
One step nucleic acid amplification of Cytokeratin 19 mRNA	6 months	One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection

Countries

Germany

Contacts

Primary ContactFiliz Oezkan, MD

filiz.oezkan@ruhrlandklinik.uk-essen.de00492014334634

Backup ContactKaid Darwiche, MD

kaid.darwiche@ruhrlandklinik.uk-essen.de00492014334552

Outcome results