Lung NeoplasmsNCT03017183
Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy
A study testing EBUS-TBNA and Endobronchial forceps biopsy in people with Lung Neoplasms, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling. Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- EBUS-TBNA and Endobronchial forceps biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2017to 31 Jul 2017
- Phase
- Interventional
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for enrolment in the study must meet all of the following criteria:
- Informed consent: a signed and dated written informed consent prior to study participation.
- Type of subject: inpatient
- Age: subjects of more than 18 years and less than 85 years.
- Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
- Central lesion has to be accessible by the biopsy techniques under investigation
Who cannot join
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
- Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl)
- Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
- Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Krankenhaus Bethanien gGmbH
Solingen, North Rhine-Westphalia, 42699
About this study
Official title: Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy
Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.
Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.
Read more
The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.
Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.
- Conditions
- Lung Neoplasms
- Being tested
- EBUS-TBNA, Endobronchial forceps biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNAProcedure or surgery
Endobronchial ultrasound guided transbronchial needle aspiration
Endobronchial forceps biopsyProcedure or surgery
Conventional endobronchial forceps biopsy
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA - Endobrochial Forceps Biopsy | Other | In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy Receives: Procedure: EBUS-TBNA; Procedure: Endobronchial forceps biopsy |
| Forceps - EBUS-TBNA | Other | In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA Receives: Procedure: EBUS-TBNA; Procedure: Endobronchial forceps biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detected mutations
The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined
Measured: within 7 days after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start2 Jan 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017183
- Sponsor's protocol ID
- WI_EBUS-TBNA_16-226
- Status last verified
- Oct 2018
- First submitted
- 5 Jan 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy
- ClinicalTrials.gov ID
- NCT03017183
- Acronym / sponsor ID
- WI_EBUS-TBNA_16-226
- Conditions
- Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- AstraZeneca, Heinrich-Heine University, Duesseldorf
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 11 Jan 2017 (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.
Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.
Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.
The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.
Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA - Endobrochial Forceps Biopsy | Other | Procedure: EBUS-TBNA, Procedure: Endobronchial forceps biopsyIn this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy |
| Forceps - EBUS-TBNA | Other | Procedure: EBUS-TBNA, Procedure: Endobronchial forceps biopsyIn this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent: a signed and dated written informed consent prior to study participation.
- Type of subject: inpatient
- Age: subjects of more than 18 years and less than 85 years.
- Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
- Central lesion has to be accessible by the biopsy techniques under investigation
Key exclusion criteria (5 listed)
- Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
- Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl)
- Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
- Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
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-TBNAEndobronchial ultrasound guided transbronchial needle aspiration | Procedure or surgery | EBUS-TBNA - Endobrochial Forceps Biopsy, Forceps - EBUS-TBNA |
| Endobronchial forceps biopsyConventional endobronchial forceps biopsy | Procedure or surgery | EBUS-TBNA - Endobrochial Forceps Biopsy, Forceps - EBUS-TBNA |
Primary outcome
Number of detected mutations
Time frame: within 7 days after biopsy
The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined
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 30 Oct 2018.
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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.
Winfried J Randerath, Prof. Dr. principal investigator
Wissenschaftliches Institut Bethanien e.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBNA and Endobronchial forceps biopsy in people with Lung Neoplasms, run by Wissenschaftliches Institut Bethanien e.V 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 5 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 30 Oct 2018. 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?
Number of detected mutations (time frame: within 7 days after biopsy). 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 30 Oct 2018.