BAL Fluid Biomarkers in Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Ability to understand and willingness to sign a written informed consent document
Diagnosed with soft tissue sarcoma
Undergoing resection of lung lesion as part of standard care
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Bronchoscopy & Metastasectomy
Procedure/SurgeryRoutine bronchoscopy and standard of care metastasectomy
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Routine Bronchoscopy & SOC MetastasectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 yearsSecondary outcomes
1
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 years2
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 years3
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 yearsSponsors and contacts
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Source ClinicalTrials.gov