Diagnosis Value of SEMA4C in Breast Cancer

Study Overview
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Brief Summary
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Breast cancer remains the most common cancer in women worldwide. Early diagnosis can greatly improve the prognosis. To date, imaging examination is still the most important diagnostic and grading tool for breast cancer. Semaphorin4C (SEMA4C) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs). The study is undertaken to evaluate the diagnostic efficiency of SEMA4C.

Detailed Description
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Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Early diagnosis and access to optimum treatment are crucial to reduce mortality associated with breast cancer. Currently, mammography and breast ultrasonography are essential for the detection and diagnosis of disease, and breast magnetic resonance imaging is the choice to estimate the extent of disease and guide appropriate treatment. However, there is no robust biomarkers for early detection of breast cancer. Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. Therefore, this prospective project aims to assess the early diagnostic value of SEMA4C as a biomarker for breast cancer.

Official Title
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Diagnosis Value of SEMA4C in Breast Cancer

Conditions
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Breast Neoplasm Female

Intervention / Treatment
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* Diagnostic Test: Breast cancer group
* Diagnostic Test: Benign breast tumor group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving no treatment before diagnosis Establishing Diagnosis according to biopsy or surgery Exclusion Criteria: Patients who are not mentally capable of giving written informed consent Clinical data missing Serum samples doesn't qualified Patients with a diagnosis of other severe acute or chronic medical conditions that may interfere with the interpretation of the study results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer group<br>Patients who have histologically confirmed new diagnosis of breast cancer are recruited. | Diagnostic Test: Breast cancer group<br>* All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.<br>|
| Benign breast tumor group<br>Patients who have histologically confirmed new diagnosis of benign breast tumors are recruited. | Diagnostic Test: Benign breast tumor group<br>* All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic potential of SEMA4C as a biomarker for breast cancer | Analyzing the predictive value of SEMA4C in the diagnosis of breast cancer. | At the time of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum SEMA4C, Mammography, breast US and MRI in comparison and combination to distinguish breast cancer from benign breast tumor | Compare and combine the diagnostic performances of Serum SEMA4C, traditional mammography, ultrasonography, and contrast-enhanced MR imaging in the assessment of breast cancer | At the time of inclusion |