Evaluation of the Concordance Between Transbronchial Needle Aspiration and Bronchoscopic Core Needle Biopsy for PD-L1 Scoring and Histology in NSCLC
C
Christopher Kniese
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
50 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Investigate PD-L1 protein expression from samples of lung masses or lymph nodes obtained by transbronchial needle aspiration (TBNA) versus core biopsy done through a specific bronchoscope that uses endobronchial ultrasound (EBUS) for localizing these targets. Currently, EBUS with TBNA is standard of care for staging and diagnosing lung cancer with treatment decisions being made based on PD-L1 expression of these samples. The concern is that TBNA may not provide a large enough sample to represent the true PD-L1 levels, and a large biopsy done by core needle is needed.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- During patient EBUS procedure, we will observe TBNA and core needle biopsy samples taken for clinical care under a microscope, and if we find non-small cell lung cancer cells we will take the additional TBNA and core needle biopsy samples for our study.
- Patients will not be eligible for this study and no additional samples will be taken if we do not find non-small cell cancer cells in initial samples.
- Patient samples will be a sent to a separate research lab for analysis and secured storage.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pulmonary Mass, Thoracic Lymphadenopathy, Lung Malignancy
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria
• Patient with radiographic evidence of a pulmonary mass, nodule and/or thoracic lymphadenopathy suspicious for lung malignancy.
• Scheduled or have a clinical plan to undergo bronchoscopy with endobronchial ultrasound (EBUS).
Exclusion Criteria
• Age < 18
• Prior diagnosis of malignancy
• Prior chemotherapy, targeted therapy or immunotherapy
• Pregnant patients
Updated on
01 Aug 2024.
Study ID: PULM-IIR-PDL1-NSCLC, 16197
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