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

• Conditions: Lung Neoplasms

• Registration Number: NCT02157857
• Lead Sponsor: University Hospital, Essen

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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One step nucleic acid amplification of Cytokeratin 19 mRNA	6 months	One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection

Trial Locations

Locations (1)

Ruhrlandklinik; 🇩🇪 Essen, NRW, Germany