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NCT Number: NCT06544668

A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

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.

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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Breast cancer patients with bone metastasis

Other

This study is an observational study

Breast cancer patients without bone metastasis

Other

This study is an observational study

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

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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