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临床试验/NCT05955092
NCT05955092招募中不适用

Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Pancreatic Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment

Peking Union Medical College Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients

研究概览

简要总结

The goal of this observational study is to test the application value of 3D bioprinting technology in personalized treatment of pancreatic cancer.

The main questions it aims to answer are:

  • Can 3D bioprinting technology be successfully applied to establish preclinical models of pancreatic cancer?
  • Can 3D bioprinted preclinical models of pancreatic cancer be applied to personalized treatment of pancreatic cancer?

Participants will have tumor tissue collected to extract primary tumor cells for the establishment of in vitro preclinical models, which will be used for drug sensitivity testing.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • More than 18 years old
  • Diagnosed as colorectal cancer with or without liver metastases before
  • Pathologically proven colorectal cancer after surgery

排除标准

  • History of other malignancies or serious medical conditions
  • Inability to provide independent informed consent

结局指标

主要结局

Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients

时间窗: From enrollment to end within 2 weeks

1. Evaluation of the efficacy of neoadjuvant therapy in clinical response using the internationally recognized Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Stable Disease (SD) and Partial Response (PR) are considered indicators of chemotherapy sensitivity (good response), while Progressive Disease (PD) is considered indicative of chemotherapy resistance (poor response). 2. Drug sensitivity testing results were assessed using standardized IC50 values. The standardized IC50 values were treated as the testing variables, while the clinical response to chemotherapy was designated as the state variable. The ROC curves for both variables were analyzed, and the area under the curve (AUC) was calculated to assess their correlation. To analyze the correlation between the drug testing results and clinical prognosis, linear regression analysis was performed to evaluate the correlation between standardized IC50 values and patients' progression-free survival (PFS) values.

次要结局

  • Progression-free survival time (PFS)(Up to 2 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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