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

NCT06889467 | Recruiting

• 1 other identifier: BRZ-0076-22
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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 evaluation (no tumor cell identified in the aspirate). Methods: A prospective feasibility study which will recruit participants with high suspicion for thoracic lymph nodes involvement in NSCLC who will be subjected to EBUS-TBNA. The final study group will comprise of 10 subjects with a negative EBUS-TBNA evaluation (no tumor cell detected) who will require surgical resection of the thoracic lymph nodes. EBUS-TBNA collected fluid will be centrifuged and separated. Cellular pellets will undergo cytological and histopathological evaluation, including tissue NGS, as usual. Cell-free DNA will be extracted from the supernatant and will undergo separate LB NGS targeted to genes frequently mutated in NSCLC. We will assess the concordance between the positivity of supernatant NGS and surgical lymph nodes staging, and the concordance between supernatant NGS and blood NGS. Expected results: We expect high concordance between surgical lymph nodes staging and supernatant NGS, that is, genetic mutations would be identified by the supernatant NGS in subjects with lymph nodes involvement by tumor, and not in those without it. Importance to Medicine: NSCLC is the leading cause of cancer mortality. Improving the effectiveness of EBUS-TBNA may reduce the need for additional invasive procedures, increase accuracy and reduce turnaround time of specimens.

Conditions

Non Small Cell Lung Cancer; Non Small Cell Lung Cancer (NSCLC); Lung Cancer (NSCLC); Lung Cancer - Non Small Cell; Pulmonary Nodule

Keywords

Endobronchial ultrasound; Endobronchial ultrasound transcbronchial needle aspiration; EBUS; EBUS-TBNA; staging; lung cancer; non small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• EBUS-TBNA NGS accuracy

  The concordance between the positivity of supernatant LB NGS and surgical lymph nodes staging in subjects with a negative EBUS-TBNA evaluation (no tumor cell detected) who will require surgical resection of the thoracic lymph nodes

  1 year

Secondary Outcomes (2)

• Accuracy of EBUS-TBNA and tissue NGS

  1 year

• peripheral blood and EBUS-TBNA concordance

  1 year

Study Arms (1)

adults with high suspicion for NSCLC

Pdult (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, will be recruited. Only subjects with a 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo surgical resection of thoracic lymph nodes for NSCLC following an EBUS-TBNA procedure which was negative for tumor cell in the thoracic lymph nodes.

You may qualify if:

• 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

You may not qualify if:

• Subjects unable or not willing to provide informed consent for study participation.
• Subjects in whom NSCLC will ultimately be ruled out.
• 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

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai University Medical Center

Ashkelon, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

supernatant fluid from EBUS-TBNA procedures peripheral blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ori Wand, MD

CONTACT

97285564421; oriw@bmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Pulmonary Medicine

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: January 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 31 Dec 2025 for 2 years
• Access Criteria: additional data will be provided following reasonable request from the PI

Locations

IL (1)