Improving Genomic Profiling and Reducing Time to Non-small Cell Lung Cancer or Lymphoma Treatment Via Targeted Use of Endoscopic Ultrasound: a Randomized Clinical Trial on the Diagnostic Accuracy of Tissue Sampling With FNA Versus FNB
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 362
- 试验地点
- 3
- 主要终点
- Conclusive diagnosis for optimal individualized treatment
研究概览
简要总结
Aim:
To investigate whether the novel 3rd generation FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided diagnosis of common deep seated thoracic malignancies (lung cancer and lymphoma).
Short study description:
Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.
280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of lung cancer is reached.
Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma or sarcoidosis is reached.
Primary outcome: proportion of patients with a comprehensive diagnostic result in each needle arm for patients with lung cancer and lymphoma / sarcoidosis.
详细描述
Overall aim:
To investigate whether the novel FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided cancer diagnosis.
Design:
Prospective multicenter randomized control superiority study.
Primary study objective:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the department of Pathology (including NGS technicians) are blinded to needle type (FNA vs FNB needle).
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
- •Suspicion of lung cancer or lymphoma based on chest CT or PET-CT
- •Lesions adjacent to the esophagus/stomach (e.g. lung tumor, enlarged/FDG-avid lymph nodes in mediastinum or retroperitoneum, left liver lobe metastasis)
排除标准
- •Other previous cancer with CT or PET-CT suggesting recurrence (e.g. pulmonary metastasis)
- •Uncorrected coagulopathies or anticoagulation treatment that cannot be discontinued
- •Pregnant or lactating women
- •CT suggesting interposed large vessels between the esophagus/stomach and target lesion
研究组 & 干预措施
FNA group
Group of patients randomized to endoscopic ultrasound (EUS-B) using the standard FNA needle
干预措施: FNA (Procedure)
FNB group
Group of patients randomized to endoscopic ultrasound (EUS-B) using the FNB needle
干预措施: FNB (Procedure)
结局指标
主要结局
Conclusive diagnosis for optimal individualized treatment
时间窗: When the pathology report is ready (typically 1 week after intervention) and up to 4 weeks after
The proportion of patients with lung cancer or Lymphoma / sarcoidosis with a comprehensive diagnostic result. Definition: In the suspected lung cancer group: Comprehensive diagnostic results = genomic analysis defined as a successful NGS (next generation sequencing) assay. In the suspected lymphoma group: Comprehensive diagnostic results = Either a lymphoma diagnosis with successful subtyping based on flowcytometry, immunohistochemistry and NGS (when in doubt) or sarcoidosis with the finding of nonnecrotizing granulomatous inflammation.
次要结局
- NGS sequencing quality(When the pathology report is ready (typically 1 week after intervention) and up to 4 weeks after)
- Diagnostic yield(When the pathology report is ready (typically 1 week after intervention) and up to 6 months after endoscopy)
- Adverse events(From endoscopy until one week after)
- Patient reported symptoms(Right before endoscopy, 1 hour after, 1 day after and 1 week after endoscopy)
- Willingness to repeat the procedure(1 hour after endoscopy)
- Re-biopsy(From endoscopy until end of follow-up (6 months))
- Time to treatment(The first day of treatment)
研究者
Uffe Bodtger
Professor
Zealand University Hospital