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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

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