Clinical trial NCT06301295: Feasibility of Targeted Bronchial Washing for Molecular Testing by Next Generation Sequencing in Early-stage Lung Cancer
Official title: Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Early-stage Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Bronchoscopy
Liquid biopsy
Lung Cancer
Next Generation Sequencing
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue
timeFrame: through study completion, an average of 1 year
measure: Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue
timeFrame: through study completion, an average of 1 year
measure: Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid
timeFrame: through study completion, an average of 1 year
measure: Turn-around time
timeFrame: through study completion, an average of 1 year
measure: Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jung-Seop Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: