A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

NCT ID: NCT06544668

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-06

Study Completion Date

2025-01-20

Brief Summary

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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

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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.

Conditions

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Breast Cancer Bone Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast cancer patients with bone metastasis

Breast cancer patients with bone metastasis

Intervention Type OTHER

This study is an observational study

Breast cancer patients without bone metastasis

Breast cancer patients without bone metastasis

Intervention Type OTHER

This study is an observational study

Interventions

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Breast cancer patients with bone metastasis

This study is an observational study

Intervention Type OTHER

Breast cancer patients without bone metastasis

This study is an observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ma Fei,MD

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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NCC4673

Identifier Type: -

Identifier Source: org_study_id

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