跳至主要内容
临床试验/NCT04474613
NCT04474613终止不适用

Use of Liquid Biopsy to Reduce Time to Treatment for Patients With Advanced Nonsquamous Non-small Cell Lung Cancer Diagnosed at Outside Sites

Case Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
2
主要终点
TTT measured in days

研究概览

简要总结

The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.

详细描述

Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results.

A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations
  • Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere.

排除标准

  • Prior therapy for this diagnosis of NSCLC
  • Prior adequate molecular testing done for the current diagnosis of NSCLC

结局指标

主要结局

TTT measured in days

时间窗: An average of 30 days

TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days).

次要结局

  • Time to actionable genetic testing results(An average of 30 days)
  • Rate of appropriate guideline-directed therapy based upon testing results(An average of 30 days)
  • Rate of actionable biomarker discovery(An average of 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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