Clinical trial NCT03662633: Diagnosis Value of SEMA4C in Breast Cancer
Official title: Diagnosis Value of SEMA4C in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm Female
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Hubei Cancer Hospital
name: Qilu Hospital of Shandong University
name: Wuhan Central Hospital
name: Xiangyang Central Hospital
name: The First People's Hospital of Jingzhou
name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2018-09-07
Enrollment: 2300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants including patients with benign breast tumors and patients with breast cancer. All cases were confirmed histopathologically according to the WHO Classification of Tumors.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic potential of SEMA4C as a biomarker for breast cancer
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Serum SEMA4C, Mammography, breast US and MRI in comparison and combination to distinguish breast cancer from benign breast tumor
timeFrame: At the time of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Qinglei Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.