跳至主要内容
临床试验/NCT07636252
NCT07636252招募中不适用

Ex Vivo Drug Response Profiling and Outcome Prediction in Lung Adenocarcinoma

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年6月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1

研究概览

简要总结

This observational study evaluates if ex-vivo lung cancer drug sensitivity testing results correlate with the driver mutations found by genetic sequencing and if it can predict treatment response.

详细描述

Non-small cell lung cancer (NSCLC) treatment decisions often rely on DNA sequencing, which only partially captures the tumor's mutational landscape and may miss other complex resistance mechanisms. Consequently, an unbiased functional drug screen is essential to rapidly identify optimal next-line therapies. Current drug sensitivity testing (DST) is limited by inefficient live tumor cells isolation. To address this, a rapid, unbiased DST platform utilizing FDA-approved targeted therapies was developed. Our approach uses malignant pleural effusions (MPEs) as a rich source of viable tumor cells. Because MPEs are highly heterogeneous, tumor cells are first identified via EpCAM flow cytometry, and the sample is enriched for tumor cells by depleting CD45+ immune cells using antibody-coated magnetic beads. These enriched tumor cells are then seeded into drug-containing plates. Following 72-hour incubation, cell viability is assessed using the CellTiter-Glo assay. Treatment efficacy is determined by the degree of reduction in cell viability at a range of drug concentrations, where the most effective treatment is the drug that reduces cell viability at the lowest concentration range.

To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure drug sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.

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

  • Presence of pleural effusion in patient with a diagnosis of a lung cancer or suspected to be diagnosed with lung cancer according to their CT imaging, who are in need for pleural effusion drainage due to shortness of breath, and are willing to donate effusion for ex-vivo drug sensitivity testing.
  • Patient's written informed consent present.
  • Ability to understand the nature of the trial and the trial related procedures and to comply with them.

排除标准

  • negative cytology for malignancy in the last 6 months

研究组 & 干预措施

Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE

干预措施: Non-Interventional Study (Other)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验