Non Small Cell Lung CancerNCT00982605
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)
An observational study of Non Small Cell Lung Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- EBUS_TBNA
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with operable non-small cell lung cancer
Who may be able to join
- Age ≥ 18 years
- Samples are collected before surgery or before any therapy
- ECOG 0 or 1
- Clinical stage I-II, T1-2, N0-1, M0)
- Surgically respectable
- Patient with enlarged med. lymphnodes (control group)
Who cannot join
- Previous RT/CHT
- Previous or current cancer of other entity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care
Heidelberg, 69126
Michael Kreuter, MD, 49 / 6221 / 396 ext. 1201, michael.kreuter@thoraxklinik-heidelberg.de
About this study
Official title: EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes
The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).
Read the detailed description
NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- EBUS_TBNA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS_TBNAProcedure or surgery
Also called EBUS-TBNA scope, Olympus Medical
EBUS during bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| non small cell lung cancer | cancer patients Receives: Procedure: EBUS_TBNA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Kreuter, MD, Study director, Thoraxklinik Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982605
- Sponsor's protocol ID
- MK01
- Status last verified
- Oct 2009
- First submitted
- 22 Sep 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Herth FJ, Annema JT, Eberhardt R, Yasufuku K, Ernst A, Krasnik M, Rintoul RC. Endobronchial ultrasound with transbronchial needle aspiration for restaging the mediastinum in lung cancer. J Clin Oncol. 2008 Jul 10;26(20):3346-50. doi: 10.1200/JCO.2007.14.9229. Epub 2008 Jun 2.
PubMed 18519953Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. doi: 10.1007/s00330-006-0497-6. Epub 2007 Jan 6.
PubMed 17206430Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006 Nov;28(5):910-4. doi: 10.1183/09031936.06.00124905. Epub 2006 Jun 28.
PubMed 16807262Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. doi: 10.1136/thx.2005.047829. Epub 2006 May 31.
PubMed 16738038Al-Haddad M, Wallace MB. Molecular diagnostics of non-small cell lung cancer using mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Cytopathology. 2006 Feb;17(1):3-9. doi: 10.1111/j.1365-2303.2006.00318.x.
PubMed 16417559
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes
- ClinicalTrials.gov ID
- NCT00982605
- Acronym / sponsor ID
- MK01
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 23 Sep 2009 (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 purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).
Detailed description
NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non small cell lung cancer | – | Procedure: EBUS_TBNAcancer patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable non-small cell lung cancer
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Samples are collected before surgery or before any therapy
- ECOG 0 or 1
- Clinical stage I-II, T1-2, N0-1, M0)
- Surgically respectable
Key exclusion criteria (2 listed)
- Previous RT/CHT
- Previous or current cancer of other entity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS_TBNAAlso: EBUS-TBNA scope, Olympus MedicalEBUS during bronchoscopy | Procedure or surgery | non small cell lung cancer |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Background: PubMed 18519953Herth FJ, Annema JT, Eberhardt R, Yasufuku K, Ernst A, Krasnik M, Rintoul RC. Endobronchial ultrasound with transbronchial needle aspiration for restaging the mediastinum in lung cancer. J Clin Oncol. 2008 Jul 10;26(20):3346-50. doi: 10.1200/JCO.2007.14.9229. Epub 2008 Jun 2.
- Background: PubMed 17206430Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. doi: 10.1007/s00330-006-0497-6. Epub 2007 Jan 6.
- Background: PubMed 16807262Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006 Nov;28(5):910-4. doi: 10.1183/09031936.06.00124905. Epub 2006 Jun 28.
- Background: PubMed 16738038Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. doi: 10.1136/thx.2005.047829. Epub 2006 May 31.
- Background: PubMed 16417559Al-Haddad M, Wallace MB. Molecular diagnostics of non-small cell lung cancer using mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Cytopathology. 2006 Feb;17(1):3-9. doi: 10.1111/j.1365-2303.2006.00318.x.
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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.
Michael Kreuter, MD study director
Thoraxklinik Heidelberg, Germany
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 Non Small Cell Lung Cancer, run by Heidelberg University 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 6 inclusion and 2 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 Oct 2009. 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 Michael Kreuter, MD (49 / 6221 / 396 ext. 1201, michael.kreuter@thoraxklinik-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982605, which also lists 5 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 Oct 2009.