Feasibility of Targeted Bronchial Washing for Molecular Testing by Next Generation Sequencing in Early-stage Lung Cancer

Pusan National University

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing

Study type: Interventional

Funder types: Other

Identifiers

NCT06301295

2402-017-136

Details and patient eligibility

About

This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ultrathin bronchoscopy with intratumoral washing

Experimental group

Description:

Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing.

Treatment:

Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing