A Companion Trial in Silico: Computing Drug Response for Cancer Patients in Clinical Trials（PRincipal-001)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- consistency
研究概览
简要总结
The goal of this observational study is to assess the performance of computational medicine technology in predicting patients response to anticancer drugs based on omics data.The main question it aims to answer is test consistency between the computing drug response and the response of real-world clinical trials. Participants will take part in silico.
详细描述
A companion trial in silico was planned to compare head-to-head with a real clinical study of anti-tumor registered new drugs to verify the consistency between the efficacy prediction results of virtual clinical studies and the efficacy results of traditional clinical trials.
Subjects simultaneously entered real world clinical trials and virtual clinical trials built by computer modeling and artificial intelligence technology. The results of traditional clinical trials were compared with those of virtual clinical trials to calculate the consistency of virtual clinical trials.
By predicting the population with consistent efficacy, locking the response population to new drugs, using the innovative technology of computational medicine, grasping the omics characteristics of the response population, and using this as a starting point to determine the target population of clinical trials, so as to determine new screening conditions, design new clinical trials, accurately match the effective population, and revolutionary change the efficiency of clinical trials, thereby shortening the process and cost of clinical trial development.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of triple-negative breast cancer
- •The subjects agreed to participate in the traditional clinical trial and signed informed consent.
- •The subjects agreed to participate in the virtual study and signed informed consent.
排除标准
- •Subjects do not meet the inclusion criteria of traditional clinical trial.
- •Subjects suffered from other cancer disease
结局指标
主要结局
consistency
时间窗: 8 weeks after the first administration of the drug for subjects
To compare the consistency of the tumor response between two cohorts. Tumor response for Patients in traditional clinical trial cohort will be assessed by New response evaluation criteria in solid tumours v1.1. Tumor response for virtual patients in virtual study will be predicted by the trained model.The efficacy prediction model will be trained using 4-5 patients evaluated for tumor response according to New response evaluation criteria in solid tumours v1.1, including at least 2 patients with Complete Response or Partial Response . The training of this model is based on the Damage Assessment of Genomic Mutations algorithm（EBioMedicine. 2021 Jul;69:103446）with the input of patients' genomic data.
次要结局
未报告次要终点