Clinical Translation Research on a Multi-omics Breast Can... | NCT07252986

ID	Type	Description	Link
2025-COMPASS-BC	Other Identifier	The Second Affiliated Hospital, Zhejiang University School of Medicine

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Dec 30, 2028Estimated

Completion Date

Dec 30, 2028Estimated

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 19, 2025

First Posted Date

Nov 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jian Huang, Head of Breast Surgery Department, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Metastatic Risk Stratification (High/Medium/Low Risk)
Group 2		Organ-Specific Metastasis (Bone/Lung/Liver/Brain)
Group 3		Non-Metastatic Control Group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metastasis-Free Survival	Time from initial breast cancer diagnosis to the occurrence of distant metastasis.	From diagnosis up to December 30, 2028

Secondary Outcomes

Measure	Description	Time Frame
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)	At the end of the study (December 2028)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Concomitant metastatic malignancy from another primary cancer.
Incomplete clinical information.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fengbo Huang, MD	Contact	0571-87783914		keyanlunli_zheer@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital, Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Description

Based on the study protocol, the following specific types of biological samples will be collected, processed, and retained:

Primary tumor tissue
Metastatic tumor tissue, specifically from liver, lung, bone, and brain metastases
Paired samples of primary and metastatic tumors (with a goal of over 1,000 pairs)
Blood samples, which will be used for liquid biopsy
The informed consent form specifies the collection of 6-10ml of peripheral blood
Data from previously retained biological samples, such as plasma
Patient-derived breast organoids All collected samples will be stored at -80°C.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases