EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Te... | NCT04159025

NCT04159025

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endobronchial ultrasound guided miniforceps biopsy	Experimental	Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique	Device: CoreDx Pulmonary Mini-Forceps

Name	Type	Description	Arm Group Labels	Other Names
CoreDx Pulmonary Mini-Forceps	Device	Manufactured by Boston Scientific	Endobronchial ultrasound guided miniforceps biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired	Adequacy will be defined as sufficient core biopsy material to perform the PD-L1 assay specific for nivolumab Any specimen in which the requested assay returns as "insufficient material to perform testing" will be deemed an "inadequate" specimen. Feasibility cannot be determined until the completion of biopsy for all patients enrolled	Completion of biopsy (day 1)

Measure	Description	Time Frame
Rate of Adverse Events		Through 24 hours after biopsy procedure

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Alexander Chen, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

References Module

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Endobronchial Ultrasound Guided Miniforceps Biopsy	Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Endobronchial Ultrasound Guided Miniforceps Biopsy	Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired

Adequacy will be defined as sufficient core biopsy material to perform the PD-L1 assay specific for nivolumab
Any specimen in which the requested assay returns as "insufficient material to perform testing" will be deemed an "inadequate" specimen.
Feasibility cannot be determined until the completion of biopsy for all patients enrolled

Posted

Count of Participants

Participants

Completion of biopsy (day 1)

ID	Title	Description
OG000	Endobronchial Ultrasound Guided Miniforceps Biopsy	Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Endobronchial Ultrasound Guided Miniforceps Biopsy	Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed. With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Alexander Chen, M.D.	Washington University School of Medicine	314-454-8764		chenac@wustl.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 26, 2021	Dec 9, 2022	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms