跳至主要内容
临床试验/NCT06815666
NCT06815666招募中2 期

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

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月29日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
70
试验地点
1
主要终点
Identification of NET-related inflammatory biomarkers using BALF and TA diagnostic tools

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: Bronchoscopy & Metastasectomy (Procedure)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • NET-related inflammatory biomarker differences for BALF and TA diagnostic tools(2 years)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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