Diagnosis Value of SEMA4C in Breast Cancer

Not yet recruiting

• Conditions: Breast Neoplasm Female
• Interventions: Diagnostic Test: Breast cancer group; Diagnostic Test: Benign breast tumor group

• Registration Number: NCT03662633
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20
• Study Start: 2023-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer group	Breast cancer group	Patients who have histologically confirmed new diagnosis of breast cancer are recruited.
Benign breast tumor group	Benign breast tumor group	Patients who have histologically confirmed new diagnosis of benign breast tumors are recruited.

Primary Outcome Measures

Name	Time	Method
Diagnostic potential of SEMA4C as a biomarker for breast cancer	At the time of inclusion	Analyzing the predictive value of SEMA4C in the diagnosis of breast cancer.

Secondary Outcome Measures

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