Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

November 17, 2023 updated by: Pusan National University Hospital
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jung Seop Eom, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 20 years
  • Obtained written informed consent
  • Subjects suspected with lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
  • Subjects who plan to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing

Exclusion Criteria:

  • Patients who withdraw informed consent
  • Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrathin bronchoscopy with intratumoral washing
Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing.
Diagnostic test: Ultrathin bronchoscopy with intratumoral washing
Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid
Time Frame: through study completion, an average of 1 year
Detection rate is defined as the number of genetic alteration with Next Generation Sequencing detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue
Time Frame: through study completion, an average of 1 year
The concordance rate of genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).
through study completion, an average of 1 year
Turn-around time
Time Frame: through study completion, an average of 1 year
The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard).
through study completion, an average of 1 year
Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid
Time Frame: through study completion, an average of 1 year
The sensitivity and specificity of genetic alteration with Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard).
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Jung-Seop Eom, MD, PhD, Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2310-011-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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