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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02157857
• Other study ID #: OSNA in EBUS-TBNA
• Status: Unknown status
• Phase: N/A
• First received: June 4, 2014
• Last updated: June 5, 2014
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: University Hospital, Essen
• Contact: Filiz Oezkan, MD
• Phone: 00492014334634
• Email: filiz.oezkan[@]ruhrlandklinik.uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Locations

Country	Name	City	State
Germany	Ruhrlandklinik	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Babar M, Madani R, Thwaites L, Jackson PA, Devalia HL, Chakravorty A, Irvine TE, Layer GT, Kissin MW. A differential intra-operative molecular biological test for the detection of sentinel lymph node metastases in breast carcinoma. An extended experience from the first U.K. centre routinely offering the service in clinical practice. Eur J Surg Oncol. 2014 Mar;40(3):282-8. doi: 10.1016/j.ejso.2013.10.030. Epub 2013 Nov 21. — View Citation

Inoue M, Hiyama K, Nakabayashi K, Morii E, Minami M, Sawabata N, Shintani Y, Nakagiri T, Susaki Y, Maeda J, Higashiyama M, Okami J, Yoshida Y, Ding J, Otomo Y, Okumura M. An accurate and rapid detection of lymph node metastasis in non-small cell lung cancer patients based on one-step nucleic acid amplification assay. Lung Cancer. 2012 Dec;78(3):212-8. doi: 10.1016/j.lungcan.2012.08.018. Epub 2012 Sep 29. — View Citation

Yasufuku K, Pierre A, Darling G, de Perrot M, Waddell T, Johnston M, da Cunha Santos G, Geddie W, Boerner S, Le LW, Keshavjee S. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1393-400.e1. doi: 10.1016/j.jtcvs.2011.08.037. Epub 2011 Oct 2. — View Citation

Outcome

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