Clinical Translation Research on a Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence (COMPASS-BC)

A Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence and Its Clinical Translation Research

Breast cancer is one of the most common malignancies in women worldwide, and distant metastasis is the main cause of poor prognosis and death. This project aims to construct a precision prediction system based on multi-omics (digital pathology, immunohistochemistry, proteomics, gene sequencing) and artificial intelligence to predict distant and organ-specific metastasis (bone, lung, liver, brain) in breast cancer, analyze its mechanisms, and provide new solutions for precision medicine.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast; Pathology

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Fengbo Huang, MD; Phone Number: 0571-87783914; Email: keyanlunli_zheer@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Fengbo Huang, MD; Phone Number: 0571-87783914; Email: keyanlunli_zheer@163.com
      • Principal Investigator: Jian Huang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises female patients diagnosed with breast cancer between 2000 and 2028, identified through participating hospital centers. This includes patients who have developed distant (organ-specific) metastasis (liver, lung, bone, or brain) and for whom primary and/or metastatic tissue samples are available.

Description

Inclusion Criteria:

1. Female patients pathologically diagnosed with breast cancer at our hospital or participating centers between January 1, 2000, and December 30, 2028.
2. Must meet one of the following: 1) Initially diagnosed with breast cancer at our hospital, has developed distant metastasis (liver, bone, lung, or brain), and has a biopsy or surgical specimen from the metastatic site stored at our hospital, with complete clinical information available. 2) Primary tumor specimen is not at our hospital, but a biopsy or surgical specimen from a distant metastatic site (liver, bone, lung, brain) is stored at our hospital.

Exclusion Criteria:

1. Concomitant metastatic malignancy from another primary cancer.
2. Incomplete clinical information.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Metastatic Risk Stratification (High/Medium/Low Risk)
Group 2; Organ-Specific Metastasis (Bone/Lung/Liver/Brain)
Group 3; Non-Metastatic Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis-Free Survival	Time from initial breast cancer diagnosis to the occurrence of distant metastasis.	From diagnosis up to December 30, 2028

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Prediction Models	Evaluate the performance of (1) the metastatic risk stratification model, (2) the organ-specific metastasis prediction model, and (3) the metastasis time-window prediction model. Measure: Accuracy and Area Under the Curve (AUC). (Target accuracy ≥80%, AUC ≥0.80)	At the end of the study (December 2028)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2025-COMPASS-BC (Other Identifier: The Second Affiliated Hospital, Zhejiang University School of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Sharing of IPD is not guaranteed and is strictly conditional. First, consent for the long-term storage and future research use of data is collected as a separate, optional item on the Informed Consent Form. Therefore, IPD cannot be shared from any participant who does not provide this specific optional consent.

Second, the study involves highly sensitive multi-modal data, including digital pathology, proteomics, and genomic sequencing. This data is subject to strict privacy-preserving protocols (such as encryption and differential privacy) and oversight by the institutional data security committee to protect participant confidentiality and prevent re-identification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No