Brief Summary

The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are:

Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.

Trial Health

On Track

Trial Health Score

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

Enrollment

839

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2023

Geographic Reach

1 country

8 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

April 11, 2023

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed

Last Updated

July 29, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

August 22, 2023

Last Update Submit

July 28, 2025

Conditions

Breast Cancer Breast Fibroadenoma Breast Hypoplasia

Keywords

cfDNADeep learning

Outcome Measures

Primary Outcomes (1)

Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
Peripheral blood samples were collected during routine physical examinations for healthy volunteers and prior to surgery for cancer patients. The blood samples were drawn and placed into cfDNA preservation tubes (Ardent BioMed, Guangdong, China, Cat. # BY10240301). After collection, the fresh blood was subjected to an initial centrifugation at 1,600 × g for 10 minutes at 4°C, allowing the plasma supernatant to be carefully separated via pipetting. This plasma was then centrifuged again at 16,000 × g for 10 minutes at 4°C to remove any residual debris. The resulting plasma supernatant was then carefully collected and stored at -80°C. The preserved plasma samples were subsequently transported on dry ice to the central laboratory at OmixScience Research Institute (Hangzhou, China).
1 year from enrollment

Secondary Outcomes (1)

Evaluate participants' TeFei™ score
60 days

Study Arms (2)

the cancer group

503 cases of early breast cancer

Genetic: cfDNA sequencing

the benign control group

289 cases of control group

Genetic: cfDNA sequencing

Interventions

cfDNA sequencingGENETIC

Multi-omics sequencing of cfDNA in peripheral venous blood.

the benign control groupthe cancer group

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Breast cancer patients and patients with benign breast diseases.

You may qualify if:

Patients ≥18 years old and ≤70 years old;
Plasma of the participant can be obtained;
Willing to sign the informed consent;
Meet one of the following criteria:
)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;

You may not qualify if:

In any of the following situations, subjects should not participate in the trial:
Pregnant or lactating;
Unable to obtain the participant's plasma;
Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
Received any blood product transfusion in the past 30 days;
Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
OmixScience Institutecollaborator

Study Sites (8)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

Affiliated Hangzhou First People's Hospital ,Westlake University School of Medicine