A Phase 2 interventional study of Bronchoscopy & Metastasectomy in Soft Tissue Sarcoma (STS), Bronchoalveolar Lavage (BAL) and Bronchoalveolar Lavage Fluid, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
This is a single-centre, Phase II, prospective study designed to assess BALF and TA-derived biomarkers in relation to metastatic burden in STS patients. BALF and TA samples will be collected during routine bronchoscopy performed as part of standard care at Toronto General Hospital (TGH). Additionally, tissue samples of lung metastases and adjacent normal lung will be collected and used to correlate the identified biomarkers.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
1. History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years
BALF and TA will be collected during routine bronchoscopy, and resected lung metastases and adjacent normal tissue will be collected during standard of care metastasectomy
Procedure: Bronchoscopy & Metastasectomy
Routine bronchoscopy and standard of care metastasectomy
Identification of NET-related inflammatory biomarkers using BALF and TA diagnostic tools
Bronchoalveolar lavage fluid (BALF) is a diagnostic tool used to sample cells and soluble substances from the lower respiratory tract. BALF allows for the examination of local immune responses and the identification of inflammatory markers. In the context of metastatic soft-tissue sarcoma, analyzing BALF can provide valuable insights into the presence and role of neutrophil extracellular traps (NETs) and other inflammatory factors within the lungs. On the other hand, tracheal aspirates (TA) can be more easily obtained from STS patients for biomarker identification.
Time frame: 2 years
Quantification of NET-related inflammatory biomarkers using BALF and TA diagnostic tool
Bronchoalveolar lavage fluid (BALF) is a diagnostic tool used to sample cells and soluble substances from the lower respiratory tract. BALF allows for the examination of local immune responses and the identification of inflammatory markers. In the context of metastatic soft-tissue sarcoma, analyzing BALF can provide valuable insights into the presence and role of neutrophil extracellular traps (NETs) and other inflammatory factors within the lungs. On the other hand, tracheal aspirates (TA) can be more easily obtained from STS patients for biomarker identification.
Time frame: 2 years
Correlation of NET-related inflammatory markers using BALF and TA diagnostic tool with the extent of metastatic dissemination
Bronchoalveolar lavage fluid (BALF) is a diagnostic tool used to sample cells and soluble substances from the lower respiratory tract. BALF allows for the examination of local immune responses and the identification of inflammatory markers. In the context of metastatic soft-tissue sarcoma, analyzing BALF can provide valuable insights into the presence and role of neutrophil extracellular traps (NETs) and other inflammatory factors within the lungs. On the other hand, tracheal aspirates (TA) can be more easily obtained from STS patients for biomarker identification.
Time frame: 2 years
Analysis of NET-related inflammatory biomarkers using BALF and TA diagnostic tool
Comparative analysis of NET-related inflammatory biomarkers in BALF and tracheal aspirates. Collected specimens will undergo comprehensive multi-omic analysis, encompassing proteomic, transcriptomic, and DNA sequencing methodologies to characterize the molecular landscape of disease progression associated with NETs.
Time frame: 2 years
Correlation between NET-related inflammatory biomarkers using BALF and TA diagnostic tool
Correlation between the identified markers in BALF and tracheal aspirates with those found in resected pulmonary metastases and adjacent normal lung. The integration of these data will enable the identification of correlations between local and systemic disease features, uncovering potential biomarkers and pathways relevant to tumor progression and therapeutic targeting.
Time frame: 2 years
NET-related inflammatory biomarker differences for BALF and TA diagnostic tools
Assessment of any differences in NET-related inflammatory biomarker profiles between patients with different metastatic burdens. For BALF and TAs, the supernatant will be analyzed to identify inflammatory biomarkers and NET-associated proteins, while cellular components will be subjected to RNA sequencing for transcriptomic profiling and DNA sequencing to explore genetic and epigenetic modifications.
Time frame: 2 years
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University Health Network, Toronto