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Establishment of Patient Derived Cancer Cell Models to Interrogate Novel Molecular Targets in Metastatic Cancer

2022年6月13日 更新者:Jeeyun Lee、Samsung Medical Center

With rapid advances in molecular oncology, the availability of preclinical in vitro cell models and in vivo animal models with specific genomic aberrations is critical for improved prediction of clinical outcomes in cancer patients. One of the most widely used preclinical models is conventional cell lines, such as the NCI-60 panel of cell lines;these cell lines are widely used in preclinical testing for novel targeted drugs, partially owing to the low expense and reduced labor associated with cell culture compared with other preclinical models, such as animal xenografts. However, recent studies have shown that accumulation of genetic aberrations in cancer cell lines occurs with increasing passage number. These models also lack the heterogeneity of tumors and do not exhibit a proper microenvironment, highlighting the limitations of cell-based models. Consistent with this, Johnson et al. demonstrated that in vivo activities of the cell lines within the NCI-60 panel did not closely correlate with corresponding human cancers.

Therefore, to better preserve the genomic integrity and tumor heterogeneity observed in patients, patient-derived xenograft (PDX) models are being used more frequently. PDX is generated by directly transplanting freshly resected patient tumors into immunocompromised murine hosts with or without an intermediate in vitro culture step. This PDX model is an improvement over cell lines because it can provide both an appropriate tumor microenvironment and heterogeneity of tumor cells. However, the engraftment success rates and growth rates of implanted tumors are highly variable depending on the tumor type, possibly due to insufficient numbers of hematopoietic cells and/or ineffective microenvironmental cues in the mouse stroma. The extent to which tumor cells from freshly resected tumors are able to withstand mechanical stresses and xenotransplantation barriers is also unclear. Furthermore, the use of PDX models for application in clinical oncology is limited owing to the time required for PDX establishment (> 4 months) since most patients with refractory cancer live less than 1 year. Recently, PDC line models have been suggested as an alternative preclinical model to be used as a prediction tool for preclinical drug sensitivity.

Therefore, in this study, the investigators aimed to overcome these potential barriers of pre-existing models by examining the capacity of PDC line models to recapitulate the histological and genomic features of primary patient tumors. In selected cases, the investigators screened drug sensitivity in vitro using PDC lines and compared the results with real-life clinical treatment outcomes.

研究概览

研究类型

观察性的

注册 (预期的)

500

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

    • Korea
      • Seoul、Korea、大韩民国、135-720
        • 招聘中
        • Samsung Medical Center
        • 接触:
          • yoon jeong ahn
          • 电话号码:82-2-2148-7395
        • 首席研究员:
          • Jeeyun Lee, MD, PhD

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

inclusion criteria are as follows: age ≥ 18 years; pathologically confirmed solid cancer; presence of metastatic lesion(s) not amenable to surgical treatment and having malignant effusion in the body cavity which needed to be drained by percutaneous methods for therapeutic purpose.

描述

Inclusion Criteria:

  • Patients older than 18 years.
  • Patients with histologically confirmed cancer
  • Written informed consent form
  • Presence of metastatic lesion(s) not amenable to surgical treatment and having malignant effusion in the body cavity which needed to be drained by percutaneous methods for therapeutic purpose.

Exclusion Criteria:

  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.

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
干预/治疗
molecular profiling, patient derived cells

molecular profiling,patient derived cells sample and experimental methods-Blood sample,tumor tissue or primary cultures of human effusions.

Malignant ascites, pleural effusions, or pericardial effusions will be collected from patients with metastatic cancer.

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
molecular screening(collected of blood,tumor tissue Malignant ascites, pleural effusions, or pericardial effusions will be analyzed)
大体时间:At the time of study entry.
To determine the feasibility of the use of patient derived tumor cell models - molecular profiling to direct targeted therapies in the treatment of refractory solid tumors
At the time of study entry.
The success rate of patient derived tumor cell model establishment
大体时间:2 years
2 years

次要结果测量

结果测量
大体时间
总生存期
大体时间:2年
2年
无进展生存期
大体时间:2年
2年
反应持续时间
大体时间:2年
2年

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。

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)

2016年2月4日

初级完成 (预期的)

2022年6月1日

研究完成 (预期的)

2023年6月1日

研究注册日期

首次提交

2016年1月3日

首先提交符合 QC 标准的

2016年1月4日

首次发布 (估计)

2016年1月5日

研究记录更新

最后更新发布 (实际的)

2022年6月15日

上次提交的符合 QC 标准的更新

2022年6月13日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2015-12-154

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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