Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. The main questions it aims to answer are: compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population. construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients. Participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. When necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.

Official Title
-----------------
Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Conditions
-----------------
Breast Neoplasm Female

Intervention / Treatment
-----------------
* Diagnostic Test: Collect blood and urine，pathological specimens if necessary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signing the consent of informedness; Patients with breast mass who need surgery after examination; Cardiac ultrasound indicates that the blood score of the heart is within the normal range; ECOG≤0-2 points; Oversure function is acceptable. Exclusion Criteria: Merge other malignant tumors such as gynecologic oncology; After evaluation, the internal organs are not suitable.

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br>No intervention. The patients who are diagnosed as breast cancer by postoperative pathological. | Diagnostic Test: Collect blood and urine，pathological specimens if necessary<br>* Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube<br>|
| Patients with benign breast lesions<br>No intervention. The patients who are diagnosed asbenign breast lesions by postoperative pathological. | Diagnostic Test: Collect blood and urine，pathological specimens if necessary<br>* Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube<br>|
| Healthy population<br>No intervention. The volunteers. | Diagnostic Test: Collect blood and urine，pathological specimens if necessary<br>* Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The different biomarkers in malignant and benign breast diseases | By analyzing the differences (eg:PCA, FC and et al.)in the composition of proteins in blood and urine, biomarkers with significant differences between the two groups will be obtained. | It is expected to be one to two years. | 
| Diagnostic models used different biomarkers by machine learning | Using biomarkers that detect discrepancies, combined with machine learning to build early breast cancer diagnostic models. | Within half a year after the completion of the test. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serum and Urine Biomarkers,Machine Learning,Diagnostic Model