Exploring a Breast Cancer Early Screening Model Based on cfDNA

Completed

• Conditions: Breast Cancer; Breast Fibroadenoma; Breast Hypoplasia
• Interventions: Genetic: cfDNA sequencing

• Registration Number: NCT06016790
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-11
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-30
• Primary Completion: 2023-12-13
• Study Completion: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

1. Patients ≥18 years old and ≤70 years old;
2. Plasma of the participant can be obtained;
3. Willing to sign the informed consent;
4. Meet one of the following criteria:

4.1)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;

Exclusion Criteria

In any of the following situations, subjects should not participate in the trial:

1. Pregnant or lactating;
2. Unable to obtain the participant's plasma;
3. Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
4. The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
5. Received any blood product transfusion in the past 30 days;
6. Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the cancer group	cfDNA sequencing	200 cases of early breast cancer (stage I-IIa breast cancer, and breast carcinoma in situ) and 80 cases of middle and advanced breast cancer (stage IIb, IIc, III, IV)
the benign control group	cfDNA sequencing	200 cases of control group (100 cases of breast hyperplasia, 100 cases of breast fibroma)

Primary Outcome Measures

Name	Time	Method
Evaluate the sensitivity and specificity of the early detection model for breast cancer screening	1 year from enrollment	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate participants' TeFei™ score	60 days	This test is based on the expression level of key genes in the cfDNA tumor of the participant's blood sample, and the relative expression level of these genes is calculated to obtain a score. This score is called the TeFei™ Score and usually ranges from 0 to 100, with a higher score indicating a higher tumor burden in the patient.

Trial Locations

Locations (8)

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, Anhui, China

Affiliated Hangzhou First People's Hospital ,Westlake University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Wenhui Community Health Service center, Gongshu district, Hangzhou city; 🇨🇳 Hangzhou, Zhejiang, China

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Affiliated With Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Provincial Hospital Of Traditional Chinese Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang, China