Lung CancerNCT02157194
Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division
An observational study of Lung Cancer, run by University Hospital, Essen at 1 site in Germany.
Trial summary
EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects suspected to have lung cancer and enlarged mediastinal lymph nodes
Who may be able to join
- clinical diagnosis of lung cancer
- enlarged mediastinal or hilar lymph nodes (>10 mm)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of lung cancer diagnosis
We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis
Measured: 6 month
Secondary outcomes (1)
Percentage of successful performed molecular RNA based analysis
We will analyse the second half of the sample regarding molecular analysis. RNA concentration and RNA integrity score will be assessed before a new RNA based test will be evaluated.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaid Darwiche, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157194
- Sponsor's protocol ID
- RLK-EBUS-2
- Other IDs
- 11-4921-BO
- Status last verified
- Oct 2016
- First submitted
- 1 Jun 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division
- ClinicalTrials.gov ID
- NCT02157194
- Acronym / sponsor ID
- RLK-EBUS-2
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 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.
EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suspected to have lung cancer and enlarged mediastinal lymph nodes
Key inclusion criteria (2 listed)
- clinical diagnosis of lung cancer
- enlarged mediastinal or hilar lymph nodes (>10 mm)
Key exclusion criteria (1 listed)
- -
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
Sensitivity and Specificity of lung cancer diagnosis
Time frame: 6 month
We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis
1 secondary outcome
Percentage of successful performed molecular RNA based analysis
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, 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 2 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: finished, as of the sponsor's last update on 26 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of lung cancer diagnosis (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.