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Clinical Trials/NCT06544668
NCT06544668
Not yet recruiting
Not Applicable

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country3,500 target enrollmentAugust 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
3500
Locations
1
Primary Endpoint
To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2024
End Date
January 20, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ma Fei,MD

Chief physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with breast cancer by histopathology;
  • Age between 20 and 70 years old;
  • The first diagnosis time is between 2010 and 2020;
  • 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.;
  • Sufficient available follow-up information.

Exclusion Criteria

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

Outcomes

Primary Outcomes

To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients

Time Frame: 60 months

The correlation between clinical characteristics and bone metastasis, and the accuracy of prediction model

Study Sites (1)

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