BAL Fluid Biomarkers in Sarcoma

NCT06815666 | Recruiting Phase 2

• 1 other identifier: 24-5871
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 years

Secondary Outcomes (3)

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

  2 years

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

  2 years

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

  2 years

Study Arms (1)

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

Procedure: Bronchoscopy & Metastasectomy

Interventions

Bronchoscopy & Metastasectomy PROCEDURE

Routine bronchoscopy and standard of care metastasectomy

Routine Bronchoscopy & SOC Metastasectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Bronchoscopy; Metastasectomy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

David Shultz

CONTACT

416-946-4501; david.shultz@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 7, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CA (1)