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Standardization of a Platform of Preclinical Models Derived From NSCLC Patients

2026年6月4日 更新者:Regina Elena Cancer Institute

Standardization of a Platform of Preclinical Models Derived From NSCLC Patients to Investigate the Efficacy of New Nutraceutical Compounds Used as Monotherapy or in Combination With Immunotherapeutics or Chemo-immunotherapy

Characterize and trace innovative nutraceuticals based on microencapsulated resveratrol and Cynara cardunculus extract, using preclinical models such as organotypic tissue slices and tumoroids created from tumor fragments derived from patients with non-small cell lung cancer. This will enable the development of combination therapies to increase the efficacy of immunotherapy in NSCLC and reduce side effects that lead to treatment discontinuation.

The market implementation of these products may offer unique advantages, including increased clinical efficacy, improved tolerability of immune checkpoint inhibitors, reduced healthcare costs, improved quality of life for patients and their families, traceability of naturally derived products, and environmental sustainability.

研究概览

地位

招聘中

详细说明

Aimed at conducting research and development activities to characterize nutraceutical compounds with reduced environmental impact, increased bioavailability, and efficacy, including in cases of resistance to traditional anticancer therapies, thanks to innovative microencapsulation technology; the standardization of a platform of patient-derived organotypic models to evaluate the efficacy of new compounds, in combination with immunotherapy, in lung cancer; the implementation of advanced traceability models and products throughout the supply chain leading to the use of naturally derived products for human health.

Three different work packages conducted individually by the individual partners.

Specifically, the IRCCS Istituto Nazionale Tumori Regina Elena will lead and coordinate the activities related to the standardization of preclinical models derived from NSCLC patients to evaluate the efficacy of new nutraceutical compounds used as monotherapy or in combination with immunotherapies. In detail, the aim is to standardize and analyze with spatial transcriptomics a tissue slice and tumoroid platform to evaluate the efficacy of new microencapsulated nutraceutical compounds in combination with immunotherapy in patients with lung cancer. The prospective, non-pharmacological, biological pilot study involves the collection and use of samples from prospectively recruited patients affected by untreated non-small cell lung cancer who have undergone curative surgery at the Thoracic Oncology Unit of the Regina Elena Cancer Institute in Rome. Samples will be appropriately analyzed and will meet the inclusion criteria.

研究类型

观察性的

注册 (估计的)

5

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Rome
      • Rome、Rome、意大利、00144
        • 招聘中
        • IRCCS National Cancer Institute "regina Elena"
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with untreated NSCLC who will undergo curative surgery

描述

Inclusion criteria:

  • Patients over 18 years of age;
  • Patients diagnosed with resectable NSCLC who will undergo curative surgery;
  • Patients who give written informed consent (study participation and data processing).

Exclusion criteria:

  • Previous malignancies;
  • Previous systemic treatments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with untreated non-small cell lung cancer
Patients with untreated non-small cell lung cancer who will undergo curative surgery at the Thoracic Oncology Unit of the Regina Elena Cancer Institute in Rome were prospectively recruited.

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
Efficacy of microencapsulated nutraceutical compounds.
大体时间:9 months
To investigate the efficacy of novel microencapsulated nutraceutical compounds in combination with immunotherapy in patients with lung cancer. Efficacy is measured as directly proportional to the binding created between the drug and the receptor.
9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Paola Nisticò, Medical Doctor、IRCCS "Regina Elena" National Cancer Institude

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月24日

初级完成 (实际的)

2026年4月24日

研究完成 (估计的)

2026年7月24日

研究注册日期

首次提交

2025年11月18日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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