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NCT Number: NCT06815666

BAL Fluid Biomarkers in Sarcoma

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.

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Key information

Conditions

Soft Tissue Sarcoma (STS) Bronchoalveolar Lavage (BAL) Bronchoalveolar Lavage Fluid Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

David Shultz

CONTACT

[email protected]

416-946-4501 ext. 2121

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years

Treatment and study plan

Bronchoscopy & Metastasectomy

Procedure

Routine bronchoscopy and standard of care metastasectomy

Primary outcomes

  1. Identification of NET-related inflammatory biomarkers using BALF and TA diagnostic tools

    Time frame: 2 years

    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.

  2. Quantification of NET-related inflammatory biomarkers using BALF and TA diagnostic tool

    Time frame: 2 years

    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.

  3. Correlation of NET-related inflammatory markers using BALF and TA diagnostic tool with the extent of metastatic dissemination

    Time frame: 2 years

    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.

Secondary outcomes

  1. Analysis of NET-related inflammatory biomarkers using BALF and TA diagnostic tool

    Time frame: 2 years

    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.

  2. Correlation between NET-related inflammatory biomarkers using BALF and TA diagnostic tool

    Time frame: 2 years

    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.

  3. NET-related inflammatory biomarker differences for BALF and TA diagnostic tools

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Shultz

CONTACT

[email protected]

416-946-4501 ext. 2121

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Feb 7, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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