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NCT Number: NCT06301295

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital

Busan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Ultarthin bronchoscopy with intratumoral washing

Diagnostic Test

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.

Primary outcomes

  1. The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing

    Time frame: through study completion, an average of 1 year

    Diagnostic accuracy is defined as the number of true positive and true negative genetic alterations detected by Next Generation Sequencing, divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy.

Secondary outcomes

  1. Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue

    Time frame: through study completion, an average of 1 year

    Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Clinically significant actionable mutations are defined as genes with corresponding drugs, either approved or under clinical trial (e.g., EGFR, ALK, ROS1, BRAF V600E, RET, NTRK, KRAS G12C, FGFR3, or HER2).

  2. Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue

    Time frame: through study completion, an average of 1 year

    The concordance rate of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid, compared with plasma and tissue (gold standard).

  3. Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid

    Time frame: through study completion, an average of 1 year

    The sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard).

  4. Turn-around time

    Time frame: through study completion, an average of 1 year

    The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard).

  5. Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue

    Time frame: through study completion, an average of 1 year

    Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Co-mutations are defined as the occurrence of two or more genetic alterations within the same tumor cells in an individual, including at least one actionable mutation (e.g., TP53, DNMT3A, TET2, CTNNB1, PIK3CA, RB1, STK11).

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Early-stage Non-small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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