A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

NCT06544668 | Not Yet Recruiting

• 1 other identifier: NCC4673
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Bone Metastases

Outcome Measures

Primary Outcomes (1)

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

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

  60 months

Study Arms (2)

Breast cancer patients with bone metastasis

Other: Breast cancer patients with bone metastasis

Breast cancer patients without bone metastasis

Other: Breast cancer patients without bone metastasis

Interventions

Breast cancer patients with bone metastasis OTHER

This study is an observational study

Breast cancer patients with bone metastasis

Breast cancer patients without bone metastasis OTHER

This study is an observational study

Breast cancer patients without bone metastasis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3500 breast cancer patients diagnosed between 2010 and 2020.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 6, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)