A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

August 5, 2024 updated by: Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

3500 breast cancer patients diagnosed between 2010 and 2020.

Description

Inclusion Criteria:

  1. Patients diagnosed with breast cancer by histopathology;
  2. Age between 20 and 70 years old;
  3. The first diagnosis time is between 2010 and 2020;
  4. 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.;
  5. Sufficient available follow-up information.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients with bone metastasis
Other: Breast cancer patients with bone metastasis
This study is an observational study
Breast cancer patients without bone metastasis
Other: Breast cancer patients without bone metastasis
This study is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 6, 2024

Primary Completion (Estimated)

January 20, 2025

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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