Actively Recruiting

Age: 18Years +
All Genders
ID06889467

Validation of Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer: A Feasibility Study

Led by Barzilai Medical Center · Updated on 2025-03-26

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether analyzing the fluid leftover from a lung cancer staging procedure called Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) can help detect cancer spread to lymph nodes in patients with non-small cell lung cancer (NSCLC). This is important because up to 15% of EBUS-TBNA procedures do not provide enough information to confirm lymph node involvement, often requiring more invasive surgery for accurate diagnosis. The study aims to see if genetic testing of the fluid's liquid biopsy can give additional information when the standard test is negative. The study will include adults suspected of having NSCLC with possible lymph node involvement who are scheduled for EBUS-TBNA. During the procedure, samples are collected and separated into cell pellets for standard testing and fluid supernatant for liquid biopsy next generation sequencing (NGS). Participants with negative EBUS-TBNA results who then proceed to surgical lymph node removal will have their surgery samples compared with the liquid biopsy results to assess the accuracy of this new method. Participants will undergo the EBUS-TBNA procedure with fluid collection and later surgical lymph node removal as part of their care. Researchers will analyze genetic mutations found in the fluid and compare them to surgical pathology and blood tests. They will measure how well the liquid biopsy matches surgical findings over one year, helping to evaluate if this method could reduce the need for additional invasive procedures in the future.

CONDITIONS

Brief Title

Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age 18 years or older) patients suspected of having non-small cell lung cancer with thoracic lymph nodes involvement based on clinical judgment and imaging
  • Planned for an Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedure
  • Subjects with negative EBUS-TBNA results (no evidence of lymph node involvement by tumor according to histology) who will require surgical resection of the thoracic lymph nodes
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent for study participation
  • Non-small cell lung cancer ruled out
  • Not requiring surgical resection of thoracic lymph nodes or not undergoing such procedure at the study medical center

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of procedure

Participants undergo an Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedure, where thoracic lymph nodes are sampled and supernatant fluid is collected for liquid biopsy analysis.

1 visit (in-person)

Surgical Resection

Duration - Up to several days depending on clinical scheduling

Participants with negative EBUS-TBNA results who require surgical resection of thoracic lymph nodes undergo surgery to obtain tissue for further pathological staging and molecular testing.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored post-surgery to assess concordance of liquid biopsy and tissue testing results, and to inform treatment decisions.

Follow-up visits as clinically indicated

Trial Site Locations

Total: 1 location

1

Barzilai University Medical Center

Ashkelon, Israel

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Research Team

O

Ori Wand, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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