Lung NeoplasmsNCT02157857
One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples
An observational study of Lung Neoplasms, run by University Hospital, Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- CT-scan suspicious for lung cancer,
- enlarged mediastinal lymph nodes (>10 mm),
- EBUS-TBNA to be performed,
- age: 18-99 years
Who cannot join
- age: <18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ruhrlandklinik
Essen, North Rhine-Westphalia, 45239
Filiz Oezkan, MD, 00492014334634, filiz.oezkan@ruhrlandklinik.uk-essen.de
Kaid Darwiche, MD, 00492014334552, kaid.darwiche@ruhrlandklinik.uk-essen.de
About this study
Official title: A Molecular Test for Rapid On-site Evaluation in EBUS-TBNAsamples of Lung Cancer Patients
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.
Read the 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.
- Conditions
- Lung Neoplasms
- Keywords
- NSCLC, SCLC, lung cancer, EBUS-TBNA
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
One step nucleic acid amplification of Cytokeratin 19 mRNA
One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Oezkan, University Hospital, Essen
- Investigators
- Kaid Darwiche, MD, Study director, University Hospital, EssenFiliz Oezkan, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157857
- Sponsor's protocol ID
- OSNA in EBUS-TBNA
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21963329Inoue 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.
PubMed 23026640Babar 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.
PubMed 24331309Oezkan 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.
PubMed 26455862
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Test for Rapid On-site Evaluation in EBUS-TBNAsamples of Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02157857
- Acronym / sponsor ID
- OSNA in EBUS-TBNA
- Conditions
- Lung Neoplasms
- Keywords
- NSCLC, SCLC, lung cancer, EBUS-TBNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- CT-scan suspicious for lung cancer,
- enlarged mediastinal lymph nodes (>10 mm),
- EBUS-TBNA to be performed,
- age: 18-99 years
Key exclusion criteria (1 listed)
- age: <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One step nucleic acid amplification of Cytokeratin 19 mRNA
Time frame: 6 months
One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Background: PubMed 21963329Yasufuku 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.
- Background: PubMed 23026640Inoue 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.
- Background: PubMed 24331309Babar 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.
- Derived from this study: PubMed 26455862Oezkan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaid Darwiche, MD study director
University Hospital, Essen
Filiz Oezkan, MD principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filiz Oezkan, MD (00492014334634, filiz.oezkan@ruhrlandklinik.uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One step nucleic acid amplification of Cytokeratin 19 mRNA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157857, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.