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Trial Title:
Feasibility of Targeted Bronchial Washing for Molecular Testing by Next Generation Sequencing in Early-stage Lung Cancer
NCT ID:
NCT06301295
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:
Ultarthin bronchoscopy with intratumoral washing
Description:
Each subject suspected of early-stage, resectable lung cancer will undergo bronchooscopic
procedure. Ultrathin bronchoscope is inserted and placed within tumor under radial EBUS,
virtual bronchoscopic navigation, and fluoroscopy guidance. Subsequently, intratumoral
washing is performed. After undergoing surgery for suspected early-stage lung cancer, the
analysis of next generation sequencing is conducted on intratumoral washing, tissue from
surgical specimen, and blood.
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 suspicious of
early-stage lung cancer.
Criteria for eligibility:
Criteria:
1. Inclusion Criteria:
- Age ≥ 20 years
- Obtained written informed consent
- Subjects suspected of having resectable lung cancer on computed tomography
- Subjects without contraindication to brochoscopy
- Subjects planning to undergo surgery for suspected lung cancer and opting for
tissue or liquid biopsy for genetic alteration using Next Generation Sequencing
2. 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
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
Start date:
May 29, 2024
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/NCT06301295