PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST

Active, not recruiting

• Conditions: Cancer

• Registration Number: NCT06979921
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This study is a retrospective and prospective study aimed to develop and validate the performance of multi-omics assays for early detection of female breast cancer. The study will enroll approximately 496 participants including participants with breast cancers and participants with breast benign diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-10
• Study First Submitted: 2022-05-29
• Primary Completion: 2023-05-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 496

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.	48 months
The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.	48 months
The sensitivity and specificity of blood miRNA in the detection of breast cancer.	48 months

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of the multi-omics model in the detection of breast cancer.	48 months
The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.	48 months

Trial Locations

Locations (2)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China

The Affiliated Hospital of Medical College Qingdao University; 🇨🇳 Qingdao, Shandong, China