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BAL Fluid Biomarkers in Sarcoma

Prospective Study of Biomarkers Derived From Bronchoalveolar Lavage Fluid to Predict Outcomes in Soft-Tissue Sarcomas

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815666
Enrollment
70
Registered
2025-02-07
Start date
2025-01-29
Completion date
2032-04-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoalveolar Lavage (BAL), Bronchoalveolar Lavage Fluid, Soft Tissue Sarcoma (STS)

Brief summary

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.

Interventions

PROCEDUREBronchoscopy & Metastasectomy

Routine bronchoscopy and standard of care metastasectomy

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. Ability to understand and willingness to sign a written informed consent document 3. Diagnosed with soft tissue sarcoma 4. Undergoing resection of lung lesion as part of standard care

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of NET-related inflammatory biomarkers using BALF and TA diagnostic tools2 yearsBronchoalveolar 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.
Quantification of NET-related inflammatory biomarkers using BALF and TA diagnostic tool2 yearsBronchoalveolar 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.
Correlation of NET-related inflammatory markers using BALF and TA diagnostic tool with the extent of metastatic dissemination2 yearsBronchoalveolar 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.

Secondary

MeasureTime frameDescription
Analysis of NET-related inflammatory biomarkers using BALF and TA diagnostic tool2 yearsComparative 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.
Correlation between NET-related inflammatory biomarkers using BALF and TA diagnostic tool2 yearsCorrelation 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.
NET-related inflammatory biomarker differences for BALF and TA diagnostic tools2 yearsAssessment 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.

Countries

Canada

Contacts

CONTACTDavid Shultz
david.shultz@uhn.ca416-946-4501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026