OPTimizing Endobronchial Ultrasound Sampling In Suspected Non Small Cell Lung Cancer for Molecular Markers : A Pragmatic Randomized Controlled TriaL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node
研究概览
简要总结
In this monocentric randomized controlled trial, 120 potential non small cell lung cancer (NSCLC) patients for which tissue diagnosis and material for next generation sequencing (NGS) is required for clinical management will be approached the day of their endobronchial ultrasound to participate in the study. They will be randomized to 2 vs 3 passes/lymph node and will all undergo liquid biopsy. The co-primary outcomes are 1)the rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node and 2)the percentage of patients for which liquid biopsy allows to identify clinically pertinent findings not available from tissue biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Pathologist will be blinded to study arm when analyzing samples
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed NSCLC requiring tissue sample for NGS testing to guide clinical management
- •Presence of at least 2 targets accessible by EBUS or EUS suspicious of malignancy (primary tumor, lymph node > 10mm or with Standardized Uptake Value (SUV) > 2.5)
排除标准
- •Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing
研究组 & 干预措施
2 passes per target on EBUS
干预措施: Endobronchial ultrasound (Procedure)
3 passes per target on EBUS
干预措施: Endobronchial ultrasound (Procedure)
结局指标
主要结局
Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node
时间窗: At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing
Cell block will be reviewed by a blinded pathologist to determine the percentage of tumor cells within the sample by increment of 5%. More than 10% of tumor cell will be considered adequate.
Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy
时间窗: At 1 month
A case for which liquid biopsy NGS testing allows to identify a genetic alteration not identified by matched tissue biopsy (tissue inadequate, insufficient for molecular testing or adequate but genetic alteration not found) will be considered a case for which liquid biopsy provided additional clinical findings
次要结局
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/patient(At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing)
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/sampling scheme(At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing)
研究者
Marc Fortin
Primary investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval