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临床试验/NCT06707519
NCT06707519招募中不适用

A Prospective, Single Center Study to Test the Validity and Feasibility of Circulating Tumor DNA in Blood, Sputum and Alveolar Fluid, as Well as Exhaled Volatile Organic Compounds as Biomarkers in Non-Small Cell Lung Cancer

St. Joseph's Healthcare Hamilton2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
2
主要终点
Recruitment rate

研究概览

简要总结

The objective of the study is to determine the feasibility of recruiting participants and using sputum, Bronchoalveolar lavage (BAL) and exhaled Volatile Organic Compounds (VOC) in addition to blood, as biological samples for detecting mutations in extracted cell-free DNA in non-small cell lung cancer (NSCLC) patients, before and after surgery, and any recurrence within a 24-month postoperative follow-up period.

This is a pilot feasibility study, proposed as a 24-month prospective, single-center, non-interventional, observational trial with NSCLC-adenocarcinoma patients indicated for resection surgery with curative intent.

详细描述

Circulating tumor DNA (ctDNA) is increased in patients with lung cancer, and may allow detecting minimal residual disease and disease recurrence, preceding radiological detection. Detecting ctDNA in bronchoalveolar lavage/Sputum was never validated and may offer advantages over blood ctDNA, and serve as a novel biomarker for lung cancer surveillance. Lung cancer detection is possible with eNose systems with a high negative predictive value and allows prediction of treatment response to PD1 inhibitors, monitoring response to PD1 inhibitors and predicting the presence of EGFR mutations. it is reasonable to anticipate exhaled VOC to aid in detection of cancer recurrence.

The study propulsion is patients undergoing surgical resection with curative intent for NSCLC, adenocarcinoma subtype at St. Joseph's Healthcare Hamilton and the Firestone Institute of Respiratory Health , above 18 years, able to provide consent. The study procedure is collecting blood, sputum, BAL samples, exhaled VOC will be collected at the following time-points/visits: (i) Visit 1 (V1): pre surgical resection; (ii) V2: immediately before discharge from hospital post-resection; (iii) V3,4,5 : 6, 12, 24 months post-surgery; (iv) V6: unscheduled at any sign of recurrence. to note, blood sputum and BAL will be collected at visit 1 and 2 from everyone and at visits 3-6 only from those who harbor a mutation of interest.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient must be at least 18 years of age
  • Patient must be able to provide consent
  • Patients undergoing surgical resection with curative intent for non-small cell lung cancer at St. Joseph's Healthcare Hamilton and Firestone Institute for Respiratory Health.

排除标准

  • Resection done with non-curative intent or metastatic disease
  • other malignancies
  • Patients with previously treated malignancy less than 5 years prior to current resection (not including skin cancer).

结局指标

主要结局

Recruitment rate

时间窗: December 2025

the proportion of eligible participants recruited (threshold \>75%)

Data completion rate

时间窗: December 2025

proportion of samples that are usable (threshold \>80%)

Safety, adverse events

时间窗: December 2025

any adverse events (threshold \<10%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yaron Shargall

Professor

St. Joseph's Healthcare Hamilton

研究点 (2)

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