Computation Prediction of Drug Response Based on Omics Data

Peking University Cancer Hospital & Institute

Status: Invitation-only

Conditions: Breast Cancer

Treatments: Other: virtual anti-cancer drug

Study type: Observational

Funder types: Other

Identifiers

NCT05833802

2022YJZ109

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinical diagnosis of triple-negative breast cancer
2. The subjects agreed to participate in the traditional clinical trial and signed informed consent.
3. The subjects agreed to participate in the virtual study and signed informed consent.

Exclusion criteria

1. Subjects do not meet the inclusion criteria of traditional clinical trial.
2. Subjects suffered from other cancer disease

Trial design

25 participants in 2 patient groups

the virtual cohort

Description:

the virtual cohort that enroll in silico clinical trial (ISCT), and will be treated by virtual anti-cancer drug.

Treatment:

Other: virtual anti-cancer drug

the real cohort

Description:

the real cohort that enroll in real word study, and will be treated by anti-cancer drug.