Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Sun Yat-sen University

Status: Enrolling

Conditions: Breast Neoplasm Female

Treatments: Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Study type: Observational

Funder types: Other

Identifiers

NCT06102018

SYSKY-2022-149-02

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signing the consent of informedness;
2. Patients with breast mass who need surgery after examination;
3. Cardiac ultrasound indicates that the blood score of the heart is within the normal range;
4. ECOG≤0-2 points;
5. Oversure function is acceptable.

Exclusion criteria

1. Merge other malignant tumors such as gynecologic oncology;
2. After evaluation, the internal organs are not suitable.

Trial design

150 participants in 3 patient groups

Breast cancer patients

Description:

No intervention. The patients who are diagnosed as breast cancer by postoperative pathological.

Treatment:

Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Patients with benign breast lesions

Description:

No intervention. The patients who are diagnosed asbenign breast lesions by postoperative pathological.

Treatment:

Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Healthy population

Description:

No intervention. The volunteers.

Treatment:

Diagnostic Test: Collect blood and urine，pathological specimens if necessary