Exploring a Breast Cancer Early Screening Model Based on cfDNA

Study Overview
=================
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.

Official Title
-----------------
Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning

Conditions
-----------------
Breast Cancer, Breast Fibroadenoma, Breast Hypoplasia

Intervention / Treatment
-----------------
* Genetic: cfDNA sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the cancer group<br>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) | Genetic: cfDNA sequencing<br>* Multi-omics sequencing of cfDNA in peripheral venous blood.<br>|
| the benign control group<br>200 cases of control group (100 cases of breast hyperplasia, 100 cases of breast fibroma) | Genetic: cfDNA sequencing<br>* Multi-omics sequencing of cfDNA in peripheral venous blood.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity and specificity of the early detection model for breast cancer screening |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate participants' TeFei™ score | 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. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cfDNA, Deep learning