Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

NCT06102018 | Unknown

• 1 other identifier: SYSKY-2022-149-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Keywords

Serum and Urine Biomarkers,Machine Learning,Diagnostic Model

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (3)

Breast cancer patients

No intervention. The patients who are diagnosed as breast cancer by postoperative pathological.

Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Patients with benign breast lesions

No intervention. The patients who are diagnosed asbenign breast lesions by postoperative pathological.

Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Healthy population

No intervention. The volunteers.

Diagnostic Test: Collect blood and urine，pathological specimens if necessary

Interventions

Collect blood and urine，pathological specimens if necessary DIAGNOSTIC_TEST

Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube

Breast cancer patients; Healthy population; Patients with benign breast lesions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

early breast cancer(Tis,T1-3N0-1M0)

You may qualify if:

• Signing the consent of informedness;
• Patients with breast mass who need surgery after examination;
• Cardiac ultrasound indicates that the blood score of the heart is within the normal range;
• ECOG≤0-2 points;
• Oversure function is acceptable.

You may not qualify if:

• Merge other malignant tumors such as gynecologic oncology;
• After evaluation, the internal organs are not suitable.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The blood sample contains DNA, but the measurement does not involve DNA. Once the project is complete, the sample will be properly disposed.

Central Study Contacts

Jieqiong Liu Ph.D.

CONTACT

13922272706; liujieqiong01@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: October 26, 2023
• Study Start: June 22, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)