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

Recruitingn/aAges 18 Years - anyAllBarzilai Medical Center
NCT06889467 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background and aim: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the gold standard of lung cancer staging, yet up to 15% of procedures produce inadequate samples for definite diagnosis or staging. In such cases, more invasive surgical procedures are usually considered. Fluid collected during EBUS-TBNA is centrifuged to produce a pellet for cell block histopathological examination , while the supernatant is usually discarded. It has been demonstrated that this supernatant can provide material for next generation sequencing (NGS) mutation analysis using liquid biopsy (LB) technics when the procedure yielded positive results (tumor cells were demonstrated in the aspirate). We wish to assess whether LB NGS of the supernatant may provide data regarding lymph nodes involvement in non-small cell lung cancer (NSCLC) in cases with a negative EBUS-TBNA evaluatio

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📋 Eligibility rules (as published)
Inclusion Criteria: * adult (age ≥18 years) patients with high suspicion for NSCLC with thoracic lymph nodes involvement (per clinical judgement and imaging studies), planned for an 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 will comprise the final study group Exclusion Criteria: 1. Subjects unable or not willing to provide informed consent for study participation. 2. Subjects in whom NSCLC will ultimately be ruled out. 3. Subjects who will not require surgical resection of thoracic lymph nodes, or who will not undergo such procedure in our Medical Center for any reason
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What it tests

  • Not listed
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Where

1 site
Barzilai University Medical Center
Ashkelon, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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