BAL Fluid Biomarkers in Sarcoma

NCT ID: NCT06815666

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2032-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Bronchoscopy & Metastasectomy

Intervention Type PROCEDURE

Routine bronchoscopy and standard of care metastasectomy

Interventions

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Bronchoscopy & Metastasectomy

Routine bronchoscopy and standard of care metastasectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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David Shultz

Role: CONTACT

416-946-4501 ext. 2121

Facility Contacts

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David Shultz

Role: primary

416-946-4501 ext. 2121

Other Identifiers

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24-5871

Identifier Type: -

Identifier Source: org_study_id

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