Recruiting
Phase 2

Biomarkers in STS

Sponsor:

University Health Network, Toronto

Code:

NCT06815666

Conditions

Soft Tissue Sarcoma (STS)

Bronchoalveolar Lavage (BAL)

Bronchoalveolar Lavage Fluid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy & Metastasectomy

Study Details

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

Soft Tissue Sarcoma (STS)

Bronchoalveolar Lavage (BAL)

Bronchoalveolar Lavage Fluid

Study ID

NCT06815666

Start date

Jan 29, 2025

Status verified date

Mar, 2026

Completion date

Apr 1, 2032

Anticipated

Primary completion date

Apr 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Routine Bronchoscopy & SOC Metastasectomy

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

Interventions

Bronchoscopy & Metastasectomy

Routine bronchoscopy and standard of care metastasectomy

Primary outcome measure

  • Identification of NET-related inflammatory biomarkers using BALF and TA diagnostic tools [ Time Frame: 2 years ]
  • Quantification of NET-related inflammatory biomarkers using BALF and TA diagnostic tool [ Time Frame: 2 years ]
  • Correlation of NET-related inflammatory markers using BALF and TA diagnostic tool with the extent of metastatic dissemination [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

David Shultz

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

Locations

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

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

David Shultz

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-04.