In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing (PRECISE-EGFR)
Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance
The PRECISE-EGFR study is a prospective, observational project designed to generate patient-derived in vitro models (cell cultures and organoids) from individuals with non-small cell lung cancer (NSCLC) carrying EGFR mutations. These models will be used to evaluate sensitivity to different anti-EGFR therapies and explore mechanisms of drug resistance.
Using residual biological samples collected during routine clinical practice, the study will not interfere with patient care. Researchers will also compare the molecular characteristics of the models with the original tumors to ensure reliability.
The overall aim is to improve precision oncology approaches, identifying the most effective treatments for specific EGFR mutation subtypes while minimizing toxicity and resistance.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：EMILIO BRIA, Prof.
- 电话号码：+39 0630156318
- 邮箱：emilio.bria@policlinicogemelli.it
研究联系人备份
- 姓名：Ilaria Marrocco, Doc
- 邮箱：ilaria.marrocco@unicatt.it
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of non-small cell lung cancer (NSCLC), regardless of the line of treatment.
- Documented presence of an EGFR mutation.
- Availability of residual biological material obtained from diagnostic or therapeutic procedures performed as part of routine clinical practice.
- Signed written informed consent for study participation.
Exclusion Criteria:
- Patients who have not provided written informed consent will be excluded from the study.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Generate in vitro cellular models derived from tumors of patients with NSCLC carrying EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
大体时间：Throughout the study, 3 years
|
The primary objective is to generate in vitro cellular models derived from tumors of patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
|
Throughout the study, 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Degree of molecular concordance between the original tumor and derived models
大体时间：Throughout the study, 3 years
|
Compare the molecular characteristics of the obtained models with those of the original tumor in order to verify their biological concordance.
|
Throughout the study, 3 years
|
|
Variation in cell viability in in vitro models following treatment with anti-EGFR drugs
大体时间：Throughout the study, 3 years
|
To explore, in an exploratory manner, the in vitro response to anti-EGFR drugs in relation to the type of EGFR mutation.
|
Throughout the study, 3 years
|
合作者和调查者
调查人员
- 首席研究员：Emlio Bria, Prof、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.