NCT06016790

Exploring a Breast Cancer Early Screening Model Based on cfDNA

Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 839 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are: * Evaluate the sensitivity and specificity of the early detection model for breast cancer screening * Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.

Conditions

• Breast Cancer
• Breast Fibroadenoma
• Breast Hypoplasia

Interventions

Type	Name	Description
GENETIC	cfDNA sequencing	Multi-omics sequencing of cfDNA in peripheral venous blood.

Timeline

• Start date: 2023-04-11
• Primary completion: 2023-12-13
• Completion: 2024-10-31
• First posted: 2023-08-30
• Last updated: 2025-07-29

Locations

8 sites across 1 country: China