NCT02157857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

June 4, 2014

Last Update Submit

June 5, 2014

Conditions

Lung Neoplasms

Keywords

NSCLC, SCLC, lung cancer, EBUS-TBNA

Outcome Measures

Primary Outcomes (1)

  • One step nucleic acid amplification of Cytokeratin 19 mRNA

    One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection

    6 months

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CT-scans suspicious for primary diagnosis of lung cancer and enlarged mediastinal lymph nodes Patients with known diagnosis of lung cancer and newly enlarged mediastinal lymph nodes

You may qualify if:

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

You may not qualify if:

  • age: \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik

Essen, North Rhine-Westphalia, 45239, Germany

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21963329BACKGROUND

  • 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.

    PMID: 23026640BACKGROUND

  • 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.

    PMID: 24331309BACKGROUND

  • Oezkan F, Khan AM, Hager T, Freitag L, Christoph D, Darwiche K. OSNA: A Fast Molecular Test Based on CK19 mRNA Concentration for Assessment of EBUS-TBNA Samples in Lung Cancer Patients. Clin Lung Cancer. 2016 May;17(3):198-204. doi: 10.1016/j.cllc.2015.09.001. Epub 2015 Sep 21.

    PMID: 26455862DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Endobronchial ultrasound-guided needle-aspiration samples

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Kaid Darwiche, MD

    University Hospital, Essen

    STUDY DIRECTOR

  • Filiz Oezkan, MD

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Oezkan, MD

CONTACT

00492014334634filiz.oezkan@ruhrlandklinik.uk-essen.de

Kaid Darwiche, MD

CONTACT

00492014334552kaid.darwiche@ruhrlandklinik.uk-essen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Filiz Oezkan

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

DE(1)