Diagnosis Value of SEMA4C in Breast Cancer

Breast Neoplasm Female Clinical Trial

Official title:

Diagnosis Value of SEMA4C in Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03662633
• Other study ID #: 2018-TJ-BCD
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2022
• Source: Tongji Hospital
• Contact: Qinglei Gao, MD, PhD
• Phone: 13871127473
• Email: qingleigao[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2300
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Diagnostic Test:
• Breast cancer group
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.
• Benign breast tumor group
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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Tongji Hospital	Hubei Cancer Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Jingzhou, Wuhan Central Hospital, Xiangyang Central Hospital

References & Publications (2)

Gurrapu S, Pupo E, Franzolin G, Lanzetti L, Tamagnone L. Sema4C/PlexinB2 signaling controls breast cancer cell growth, hormonal dependence and tumorigenic potential. Cell Death Differ. 2018 Jul;25(7):1259-1275. doi: 10.1038/s41418-018-0097-4. Epub 2018 Mar 19. — View Citation

Wei JC, Yang J, Liu D, Wu MF, Qiao L, Wang JN, Ma QF, Zeng Z, Ye SM, Guo ES, Jiang XF, You LY, Chen Y, Zhou L, Huang XY, Zhu T, Meng L, Zhou JF, Feng ZH, Ma D, Gao QL. Tumor-associated Lymphatic Endothelial Cells Promote Lymphatic Metastasis By Highly Expressing and Secreting SEMA4C. Clin Cancer Res. 2017 Jan 1;23(1):214-224. doi: 10.1158/1078-0432.CCR-16-0741. Epub 2016 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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