BreastCOMPASS-BCNCT07252986
Clinical Translation Research on a Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence
An observational study of Breast and Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Breast cancer is one of the most common malignancies in women worldwide, and distant metastasis is the main cause of poor prognosis and death. This project aims to construct a precision prediction system based on multi-omics (digital pathology, immunohistochemistry, proteomics, gene sequencing) and artificial… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast, Breast Cancer, Pathology
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises female patients diagnosed with breast cancer between 2000 and 2028, identified through participating hospital centers. This includes patients who have developed distant (organ-specific) metastasis (liver, lung, bone, or brain) and for whom primary and/or metastatic tissue samples are available.
Who may be able to join
- Female patients pathologically diagnosed with breast cancer at our hospital or participating centers between January 1, 2000, and December 30, 2028.
- Must meet one of the following: 1) Initially diagnosed with breast cancer at our hospital, has developed distant metastasis (liver, bone, lung, or brain), and has a biopsy or surgical specimen from the metastatic site stored at our hospital, with complete clinical information available. 2) Primary tumor specimen is not at our hospital, but a biopsy or surgical specimen from a distant metastatic site (liver, bone, lung, brain) is stored at our hospital.
Who cannot join
- Concomitant metastatic malignancy from another primary cancer.
- Incomplete clinical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Fengbo Huang, MD, 0571-87783914, keyanlunli_zheer@163.com
Jian Huang, MD, PhD
About this study
Official title: A Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence and Its Clinical Translation Research
Breast cancer is one of the most common malignancies in women worldwide, and distant metastasis is the main cause of poor prognosis and death. This project aims to construct a precision prediction system based on multi-omics (digital pathology, immunohistochemistry, proteomics, gene sequencing) and artificial intelligence to predict distant and organ-specific metastasis (bone, lung, liver, brain) in breast cancer, analyze its mechanisms, and provide new solutions for precision medicine.
- Conditions
- Breast, Breast Cancer, Pathology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Metastatic Risk Stratification (High/Medium/Low Risk) | |
| Group 2 | Organ-Specific Metastasis (Bone/Lung/Liver/Brain) | |
| Group 3 | Non-Metastatic Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-Free Survival
Time from initial breast cancer diagnosis to the occurrence of distant metastasis.
Measured: From diagnosis up to December 30, 2028
Secondary outcomes (1)
Performance of Prediction Models
Evaluate the performance of (1) the metastatic risk stratification model, (2) the organ-specific metastasis prediction model, and (3) the metastasis time-window prediction model.
Measure: Accuracy and Area Under the Curve (AUC). (Target accuracy ≥80%, AUC ≥0.80)
Measured: At the end of the study (December 2028)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Huang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252986
- Sponsor's protocol ID
- 2025-COMPASS-BC
- Other IDs
- 2025-COMPASS-BC
- Acronym
- COMPASS-BC
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is not guaranteed and is strictly conditional. First, consent for the long-term storage and future research use of data is collected as a separate, optional item on the Informed Consent Form. Therefore, IPD cannot be shared from any participant who does not provide this specific optional consent. Second, the study involves highly sensitive multi-modal data, including digital pathology, proteomics, and genomic sequencing. This data is subject to strict privacy-preserving protocols (such as encryption and differential privacy) and oversight by the institutional data security committee to protect participant confidentiality and prevent re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence and Its Clinical Translation Research
- ClinicalTrials.gov ID
- NCT07252986
- Acronym / sponsor ID
- COMPASS-BC / 2025-COMPASS-BC
- Conditions
- Breast, Breast Cancer, Pathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 28 Nov 2025 (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.
Breast cancer is one of the most common malignancies in women worldwide, and distant metastasis is the main cause of poor prognosis and death. This project aims to construct a precision prediction system based on multi-omics (digital pathology, immunohistochemistry, proteomics, gene sequencing) and artificial intelligence to predict distant and organ-specific metastasis (bone, lung, liver, brain) in breast cancer, analyze its mechanisms, and provide new solutions for precision medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Metastatic Risk Stratification (High/Medium/Low Risk) |
| Group 2 | – | –Organ-Specific Metastasis (Bone/Lung/Liver/Brain) |
| Group 3 | – | –Non-Metastatic Control Group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises female patients diagnosed with breast cancer between 2000 and 2028, identified through participating hospital centers. This includes patients who have developed distant (organ-specific) metastasis (liver, lung, bone, or brain) and for whom primary and/or metastatic tissue samples are available.
Key inclusion criteria (2 listed)
- Female patients pathologically diagnosed with breast cancer at our hospital or participating centers between January 1, 2000, and December 30, 2028.
- Must meet one of the following: 1) Initially diagnosed with breast cancer at our hospital, has developed distant metastasis (liver, bone, lung, or brain), and has a biopsy or surgical specimen from the metastatic site stored at our hospital, with complete clinical information available. 2) Primary tumor specimen is not at our hospital, but a biopsy or surgical specimen from a distant metastatic site (liver, bone, lung, brain) is stored at our hospital.
Key exclusion criteria (2 listed)
- Concomitant metastatic malignancy from another primary cancer.
- Incomplete clinical information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metastasis-Free Survival
Time frame: From diagnosis up to December 30, 2028
Time from initial breast cancer diagnosis to the occurrence of distant metastasis.
1 secondary outcome
Performance of Prediction Models
Time frame: At the end of the study (December 2028)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. Sharing of IPD is not guaranteed and is strictly conditional. First, consent for the long-term storage and future research use of data is collected as a separate, optional item on the Informed Consent Form. Therefore, IPD cannot be shared from any participant who does not provide this specific optional consent. Second, the study involves highly sensitive multi-modal data, including digital pathology, proteomics, and genomic sequencing. This data is subject to strict privacy-preserving protocols (such as encryption and differential privacy) and oversight by the institutional data security committee to protect participant confidentiality and prevent re-identification.
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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.
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 and Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengbo Huang, MD (0571-87783914, keyanlunli_zheer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis-Free Survival (time frame: From diagnosis up to December 30, 2028). 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 3 Mar 2026.