Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

NCT ID: NCT06102018

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-22

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasm Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

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

Collect blood and urine,pathological specimens if necessary

Intervention Type DIAGNOSTIC_TEST

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.

Collect blood and urine,pathological specimens if necessary

Intervention Type DIAGNOSTIC_TEST

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

Healthy population

No intervention. The volunteers.

Collect blood and urine,pathological specimens if necessary

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jieqiong Liu Ph.D.

Role: CONTACT

13922272706

Facility Contacts

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Jieqiong Liu

Role: primary

020-34078091

Other Identifiers

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SYSKY-2022-149-02

Identifier Type: -

Identifier Source: org_study_id

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