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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06102018
Other study ID # SYSKY-2022-149-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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