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Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06102018
Enrollment
150
Registered
2023-10-26
Start date
2022-06-22
Completion date
2024-07-01
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Female

Keywords

Serum and Urine Biomarkers,Machine Learning,Diagnostic Model

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.

Interventions

DIAGNOSTIC_TESTCollect 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

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The different biomarkers in malignant and benign breast diseasesIt 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 learningWithin 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.

Countries

China

Contacts

Primary ContactJieqiong Liu Ph.D.
liujieqiong01@163.com13922272706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026