Breast CancerNCT06544668
A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases
An observational study of Breast Cancer and Bone Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Bone Metastases
- What is being tested?
- Breast cancer patients with bone metastasis and Breast cancer patients without bone metastasis
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 3500 breast cancer patients diagnosed between 2010 and 2020.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Bone Metastases
- Being tested
- Breast cancer patients with bone metastasis, Breast cancer patients without bone metastasis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer patients with bone metastasisOther
This study is an observational study
Breast cancer patients without bone metastasisOther
This study is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with bone metastasis | Not described Receives: Other: Breast cancer patients with bone metastasis | |
| Breast cancer patients without bone metastasis | Not described Receives: Other: Breast cancer patients without bone metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start6 Aug 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544668
- Sponsor's protocol ID
- NCC4673
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Establish a Dynamic Prediction Model for Bone Metastases Based on Breast Cancer Real-world Data
- ClinicalTrials.gov ID
- NCT06544668
- Acronym / sponsor ID
- NCC4673
- Conditions
- Breast Cancer, Bone Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 6 Aug 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3500 breast cancer patients diagnosed between 2010 and 2020.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancer patients with bone metastasisThis study is an observational study | Other | Breast cancer patients with bone metastasis |
| Breast cancer patients without bone metastasisThis study is an observational study | Other | Breast cancer patients without bone metastasis |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Bone Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.