One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples
Conditions
Lung Neoplasms
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
NSCLC, SCLC, lung cancer, EBUS-TBNA
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Retrospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 95 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Ruhrlandklinik
Essen, NRW, Germany
Status: Recruiting
Contact: Filiz Oezkan, MD - 00492014334634 - filiz.oezkan@ruhrlandklinik.uk-essen.de
Start Date
February 2014
Completion Date
July 2014
Sponsors
University Hospital, Essen
Source
University Hospital, Essen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page