A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

A Clinical Study to Establish a Dynamic Prediction Model for Bone Metastases Based on Breast Cancer Real-world Data

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06544668

Enrollment

3500

Registered

2024-08-09

Start date

2024-08-06

Completion date

2025-01-20

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Breast Cancer

Brief summary

The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

Detailed description

Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(\ 70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.

Interventions

OTHERBreast cancer patients with bone metastasis

This study is an observational study

OTHERBreast cancer patients without bone metastasis

This study is an observational study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Patients diagnosed with breast cancer by histopathology; 2. Age between 20 and 70 years old; 3. The first diagnosis time is between 2010 and 2020; 4. Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.; 5. Sufficient available follow-up information.

Exclusion criteria

1. Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment); 2. With distant metastasis at the initial diagnosis; 3. Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis); 4. Other malignant tumors; 5. Unclear information about distant metastasis.

Design outcomes

Primary

Measure	Time frame	Description
To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients	60 months	The correlation between clinical characteristics and bone metastasis, and the accuracy of prediction model

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026