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
1 other identifier
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
March 3, 2026
February 1, 2026
3.1 years
November 19, 2025
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Metastasis-Free Survival
Time from initial breast cancer diagnosis to the occurrence of distant metastasis.
From diagnosis up to December 30, 2028
Secondary Outcomes (1)
Performance of Prediction Models
At the end of the study (December 2028)
Study Arms (3)
Group 1
Metastatic Risk Stratification (High/Medium/Low Risk)
Group 2
Organ-Specific Metastasis (Bone/Lung/Liver/Brain)
Group 3
Non-Metastatic Control Group
Eligibility Criteria
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.
You may qualify if:
- Female patients pathologically diagnosed with breast cancer at our hospital or participating centers between January 1, 2000, and December 30, 2028.
- 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.
You may not qualify if:
- Concomitant metastatic malignancy from another primary cancer.
- Incomplete clinical information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Biospecimen
Based on the study protocol, the following specific types of biological samples will be collected, processed, and retained: * Primary tumor tissue * Metastatic tumor tissue, specifically from liver, lung, bone, and brain metastases * Paired samples of primary and metastatic tumors (with a goal of over 1,000 pairs) * Blood samples, which will be used for liquid biopsy * The informed consent form specifies the collection of 6-10ml of peripheral blood * Data from previously retained biological samples, such as plasma * Patient-derived breast organoids All collected samples will be stored at -80°C.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Breast Surgery Department
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.