NCT03941639

Brief Summary

Breast cancer is the second leading cause of death for women around the world. Notably, most breast cancer patients die from tumor metastases in the liver, lungs, bones, or brain, not the primary tumor itself. Currently, clinicians are generally successful in treating primary tumors using standard protocols that are based on tumor sub-type and staging, as well as by the presence or absence of prognostic biomarkers. However, it remains difficult to assess in advance the likelihood of metastasis or relapse in any given patient.Physicians can only rely on regular post-treatment screening to monitor any secondary onset. By the time metastasis is detected, the golden window for treatment adjustment has often already passed. This project proposes to develop an analytical tool for predicting the likelihood of metastasis in breast cancer patients post-treatment using imaging and genomic data. We will evaluate our prediction model using prospectively-collected patient data. This new prognostic tool will enable physicians to adjust and tailor therapeutic strategies to each patient in a timely manner. Overall, the tool will personalize patient care, and improve their survival chances and quality of life.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3.1 years

First QC Date

April 25, 2019

Last Update Submit

February 11, 2025

Conditions

Keywords

breast cancermetastasisprediction

Outcome Measures

Primary Outcomes (1)

  • area under the receiver operating characteristic curve (AUC)

    AUC in percentage (%) in breast cancer metastasis prediction model

    Four years after patient recruitment

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

BGI Ltd. will provide imaging data and genomic data from 200 breast cancer patients for us. Dr. Wing Cheong Chan is a breast surgeon at the North District Hospital (NDH) and is also the surgeon in charge of breast surgery for the Hospital Authority's entire New Territories East Cluster (NTEC). He will be responsible for recruiting 200 breast cancer patients. Prof. Winnie Yeo is a clinical oncologist at the Prince of Wales Hospital (PWH) of CUHK. She will be responsible for monitoring the 200 breast cancer patients, and will collect blood samples during the follow-up period.

You may qualify if:

  • Clinical diagnosis of breast cancer
  • With mammogram
  • With surgical treatment
  • With chemotherapy, radiotherapy or both

You may not qualify if:

  • Clinical diagnosis of other major diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

This proposed project will include one retrospective study and one prospective pilot study. In retrospective study, the BGI Ltd, which company is sponsoring this project, will provide imaging data and genomic data from 200 breast cancer patients for us. In prospective study, we will recruit 200 breast cancer patients and acquire tumor tissue and blood samples for genomic data acquisition.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Weichuan Yu, Ph.D

    Department of Electronic and computer engineering, HKUST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 8, 2019

Study Start

September 1, 2019

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations