A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

Not yet recruiting

• Conditions: Bone Metastases; Breast Cancer
• Interventions: Other: Breast cancer patients with bone metastasis; Other: Breast cancer patients without bone metastasis

• Registration Number: NCT06544668
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study Start: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3500

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients with bone metastasis	Breast cancer patients with bone metastasis	-
Breast cancer patients without bone metastasis	Breast cancer patients without bone metastasis	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China