Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

October 20, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube
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
Use EDTA anticoagulant pipe to collect all blood 2ml, and collect 3ml of urine with sterile test tube
Healthy population
No intervention. The volunteers.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The different biomarkers in malignant and benign breast diseases
Time Frame: It 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.
It is expected to be one to two years.
Diagnostic models used different biomarkers by machine learning
Time Frame: Within 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.
Within half a year after the completion of the test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2022-149-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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