Exploring a Breast Cancer Early Screening Model Based on cfDNA

Zhejiang University

Status: Completed

Conditions: Breast Cancer; Breast Fibroadenoma; Breast Hypoplasia

Treatments: Genetic: cfDNA sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT06016790

ZE-OMIX-001

Details and patient eligibility

About

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.

Enrollment: 839 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

839 participants in 2 patient groups

the cancer group

Description:

503 cases of early breast cancer

Treatment:

Genetic: cfDNA sequencing

the benign control group

Description:

289 cases of control group

Treatment:

Genetic: cfDNA sequencing