Soft Tissue Sarcoma (STS)Phase 2NCT06815666
BAL Fluid Biomarkers in Sarcoma
A Phase 2 study testing Bronchoscopy & Metastasectomy in people with Soft Tissue Sarcoma (STS) and Bronchoalveolar Lavage (BAL), run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (STS), Bronchoalveolar Lavage (BAL), Bronchoalveolar Lavage Fluid
- What is being tested?
- Bronchoscopy & Metastasectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2025to 1 Apr 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, M5G 2M9
David Shultz, 416-946-4501 ext. 2121, david.shultz@uhn.ca
About this study
Official title: Prospective Study of Biomarkers Derived From Bronchoalveolar Lavage Fluid to Predict Outcomes in Soft-Tissue Sarcomas
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.
- Being tested
- Bronchoscopy & Metastasectomy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy & MetastasectomyProcedure or surgery
Routine bronchoscopy and standard of care metastasectomy
| Study group | Role | What they receive |
|---|---|---|
| Routine Bronchoscopy & SOC Metastasectomy | Experimental | 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 Receives: Procedure: Bronchoscopy & Metastasectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start29 Jan 2025
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815666
- Sponsor's protocol ID
- 24-5871
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No