Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Recruiting

• Conditions: Breast Neoplasm Female
• Interventions: Diagnostic Test: Collect blood and urine，pathological specimens if necessary

• Registration Number: NCT06102018
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-22
• Study First Submitted: 2023-05-09
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with benign breast lesions	Collect blood and urine，pathological specimens if necessary	No intervention. The patients who are diagnosed asbenign breast lesions by postoperative pathological.
Breast cancer patients	Collect blood and urine，pathological specimens if necessary	No intervention. The patients who are diagnosed as breast cancer by postoperative pathological.
Healthy population	Collect blood and urine，pathological specimens if necessary	No intervention. The volunteers.

Primary Outcome Measures

Name	Time	Method
The different biomarkers in malignant and benign breast diseases	It is expected to be one to two years.	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.
Diagnostic models used different biomarkers by machine learning	Within half a year after the completion of the test.	Using biomarkers that detect discrepancies, combined with machine learning to build early breast cancer diagnostic models.

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China