Non Small Cell Lung CancerNCT03311620
Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
A study testing Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) in people with Non Small Cell Lung Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 8 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing EBUS TBNA for evaluation of lymphadenopathy, lung nodule or mass
- Patients must have atypical lymph nodes. Atypical lymph nodes are characterized by >10mm in short axis or lymph nodes 5-10mm in short axis with atypical features.
- Age > 18 years.
- Patients must have platelets count > 50,000
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- WOCBP must agree not to get pregnant until the day of the procedure
Who cannot join
- Patients with uncorrectable coagulopathy will be excluded.
- Patients with hemodynamic instability will be excluded
- Patients with refractory hypoxemia will be excluded
- Patients with therapeutic anticoagulant that cannot be held for 2 days before and 1 day after the procedure.
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- Pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. There has been no clear consensus on which biopsy needle yields the best biopsy sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier samples with potentially smaller fragments of tissue, offering no improvement in diagnostic, yield, adequacy or sample size.
This study compares biopsy samples collected using 19g and 22g needles from patients of non small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and transbroncial needle aspiration (TBNA).
Read the detailed description
Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)
Secondary Objectives
- To compare the sample adequacy of 22g and 19g EBUS TBNA
- To compare the sample quality of 22g and 19 g EBUS TBNA
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Endobronchial ultrasound (EBUS) transbronchial needle aspirate (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.
Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)Procedure or surgery
Biopsy samples will be collected from patients scheduled to undergo EBUS TBNA using 19g and 22g needles
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial ultrasound transbronchial needle aspirate | Other | Not described Receives: Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare diagnostic yield
Diagnostic yields of 22g and 19g needles will be evaluated by two blinded cytopathologists. Diagnostic yield refers to a specific diagnosis made on the basis of EBUS TBNA samples.
Measured: 1 year
Secondary outcomes (2)
To compare the sample adequacy of 22g and 19g EBUS TBNA
Cytologic/ histologic analysis that determines the amount of sample collected with the two needles by two blinded cytopathologists
Measured: 1 year
To compare the sample quality of 22g and 19 g EBUS TBNA
Sample quality will be examined by two blinded pathologists as to whether the samples contained only tissue or were contaminated with blood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start15 May 2018
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All abnormal lymph nodes able to be visualized by EBUS will be biopsied with sequential passes until a macroscopic specimen can be seen in the sample container. Each needle size will be used to take consecutive passes until the sample is complete and each pass will consist of 15-20 agitations. The needle size to be used first will be chosen by permuted block randomization scheme by the statistician. After all passes are done with the first needle, the alternate size needle will be used to biopsy the same lymph node. Samples will be placed in separate containers of formalin. Any subsequent lymph nodes in the same patient will be biopsied with the alternate sized needle first. Further, any lung nodules or masses that can be adequately visualized by EBUS where biopsy is clinically indicated will be sampled with both 22g and 19g TBNA needles in the same fashion. However, these lesions will be randomized separately from any lymph nodes biopsied during the case.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311620
- Sponsor's protocol ID
- TH-112
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23.
PubMed 34896033
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
- ClinicalTrials.gov ID
- NCT03311620
- Acronym / sponsor ID
- TH-112
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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.
Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. There has been no clear consensus on which biopsy needle yields the best biopsy sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier samples with potentially smaller fragments of tissue, offering no improvement in diagnostic, yield, adequacy or sample size.
This study compares biopsy samples collected using 19g and 22g needles from patients of non small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and transbroncial needle aspiration (TBNA).
Detailed description
Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)
Secondary Objectives
- To compare the sample adequacy of 22g and 19g EBUS TBNA
- To compare the sample quality of 22g and 19 g EBUS TBNA
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All abnormal lymph nodes able to be visualized by EBUS will be biopsied with sequential passes until a macroscopic specimen can be seen in the sample container. Each needle size will be used to take consecutive passes until the sample is complete and each pass will consist of 15-20 agitations. The needle size to be used first will be chosen by permuted block randomization scheme by the statistician. After all passes are done with the first needle, the alternate size needle will be used to biopsy the same lymph node. Samples will be placed in separate containers of formalin. Any subsequent lymph nodes in the same patient will be biopsied with the alternate sized needle first. Further, any lung nodules or masses that can be adequately visualized by EBUS where biopsy is clinically indicated will be sampled with both 22g and 19g TBNA needles in the same fashion. However, these lesions will be randomized separately from any lymph nodes biopsied during the case.
| Arm | Type | Receives |
|---|---|---|
| Endobronchial ultrasound transbronchial needle aspirate | Other | Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing EBUS TBNA for evaluation of lymphadenopathy, lung nodule or mass
- Patients must have atypical lymph nodes. Atypical lymph nodes are characterized by >10mm in short axis or lymph nodes 5-10mm in short axis with atypical features.
- Age > 18 years.
- Patients must have platelets count > 50,000
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Key exclusion criteria (6 listed)
- Patients with uncorrectable coagulopathy will be excluded.
- Patients with hemodynamic instability will be excluded
- Patients with refractory hypoxemia will be excluded
- Patients with therapeutic anticoagulant that cannot be held for 2 days before and 1 day after the procedure.
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
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 |
|---|---|---|
| Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)Biopsy samples will be collected from patients scheduled to undergo EBUS TBNA using 19g and 22g needles | Procedure or surgery | Endobronchial ultrasound transbronchial needle aspirate |
Primary outcome
Compare diagnostic yield
Time frame: 1 year
Diagnostic yields of 22g and 19g needles will be evaluated by two blinded cytopathologists. Diagnostic yield refers to a specific diagnosis made on the basis of EBUS TBNA samples.
2 secondary outcomes
To compare the sample adequacy of 22g and 19g EBUS TBNA
Time frame: 1 year
To compare the sample quality of 22g and 19 g EBUS TBNA
Time frame: 1 year
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 8 Oct 2020.
- Derived from this study: PubMed 34896033Manley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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?
A study testing Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) in people with Non Small Cell Lung Cancer, run by Fox Chase Cancer Center at 1 site in United States.
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 6 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 8 Oct 2020. 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 United States. 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?
Compare diagnostic yield (time frame: 1 year). 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 NCT03311620, which also lists 1 linked publication.
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 8 Oct 2020.