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NCT Number: NCT07252986

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

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.

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Key information

Conditions

Breast Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathology Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Fengbo Huang, MD

CONTACT

[email protected]

0571-87783914

Jian Huang, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Concomitant metastatic malignancy from another primary cancer.
  • Incomplete clinical information.

Treatment and study plan

Primary outcomes

  1. Metastasis-Free Survival

    Time frame: From diagnosis up to December 30, 2028

    Time from initial breast cancer diagnosis to the occurrence of distant metastasis.

Secondary outcomes

  1. Performance of Prediction Models

    Time frame: At the end of the study (December 2028)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fengbo Huang, MD

CONTACT

[email protected]

0571-87783914

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: COMPASS-BC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 28, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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