Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Breast Neoplasm Female Clinical Trial

Official title:

Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102018
• Other study ID #: SYSKY-2022-149-02
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jieqiong Liu Ph.D.
• Phone: 13922272706
• Email: liujieqiong01[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Diagnostic Test:
• Collect blood and urine,pathological specimens if necessary
Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.