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Trial Title:
Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer
NCT ID:
NCT06141005
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Bronchoscopy
Liquid biopsy
Lung Cancer
Next Generation Sequencing
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Ultrathin bronchoscopy with intratumoral washing
Description:
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.
Arm group label:
Ultrathin bronchoscopy with intratumoral washing
Summary:
This is a single center, clinical trial evaluating the relevance of intratumoral washing
for detection of generic alteration with Next Generation Sequencing.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 20 years
- Obtained written informed consent
- No contraindication to bronchoscopy
- Subjects suspected of having lung cancer on computed tomography or diagnosed with
lung cancer by histology or cytology
- Subjects planning to undergo tissue or liquid biopsy for genetic alteration with
Next Generation Sequencing
Exclusion Criteria:
- Subjects who withdraw informed consent
- Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for
genetic alteration with Next Generation Sequencing based on the investigator's
judgement
- Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung
tissue lesion
- Subjects diagnosed with a benign lesion from the lung tissue lesion
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pusan National University hospital
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung Seop Eom, MD, PhD
Phone:
82-51-240-7889
Email:
ejspulm@gmail.com
Contact backup:
Last name:
Soo Han Kim, MD, PhD
Phone:
82-51-240-7889
Email:
kshyjt1004@gmail.com
Investigator:
Last name:
Jung Seop Eom, MD, PhD
Email:
Principal Investigator
Start date:
November 30, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Pusan National University Hospital
Agency class:
Other
Source:
Pusan National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141005
