Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-16 @ 8:56 PM
Study NCT ID:
NCT03311620
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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).
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
1. To compare the sample adequacy of 22g and 19g EBUS TBNA
2. To compare the sample quality of 22g and 19 g EBUS TBNA
Secondary Objectives
1. To compare the sample adequacy of 22g and 19g EBUS TBNA
2. To compare the sample quality of 22g and 19 g EBUS TBNA
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: