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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Concomitant metastatic malignancy from another primary cancer.

Incomplete clinical information.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 3 trial groups
Group A: Group 1
Group B: Group 2
Group C: Group 3

Trial outcomes

Primary outcomes

1

Metastasis-Free Survival

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

Time frame
From diagnosis up to December 30, 2028

Secondary outcomes

1

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)

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

Other outcomes

Sponsors and contacts

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