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Trial Title:
Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine
NCT ID:
NCT06102018
Condition:
Breast Neoplasm Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Serum and Urine Biomarkers,Machine Learning,Diagnostic Model
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Collect blood and urine，pathological specimens if necessary
Description:
Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with
sterile test tube
Arm group label:
Breast cancer patients
Arm group label:
Healthy population
Arm group label:
Patients with benign breast lesions
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.
Criteria for eligibility:
Study pop:
early breast cancer(Tis,T1-3N0-1M0)
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jieqiong Liu
Phone:
020-34078091
Email:
liujieqiong01@163.com
Start date:
June 22, 2022
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102018
