A Study for Dynamic Prediction Model of 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 →
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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