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Not yet recruiting NCT06544668

A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

Observational Breast Cancer Bone Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breast cancer patients with bone metastasis, Breast cancer patients without bone metastasis.
Who it may be relevant to
Registry conditions: Breast Cancer, Bone Metastases. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Breast cancer patients with bone metastasis
    This study is an observational study
  • Other Breast cancer patients without bone metastasis
    This study is an observational study

Primary outcome measures

  • To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients [Time frame: 60 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing

Identifiers

NCT: NCT06544668 · NCC4673

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗