Clinical trial NCT03663153: SEMA4C as a Relapse Biomarker in Breast Cancer
Official title: SEMA4C as a Relapse Biomarker in Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
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: 2018-09-10
Enrollment: 4200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants including 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. Semaphorin4C (SEMA4C) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs). The objective of this study is to investigate SEMA4C's potential role as an early relapse biomarker in breast cancer.

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. Although regular clinical examination, mammography, ultrasonography, and magnetic resonance imaging can detect some recurrence patients, the lack of robust biomarkers for monitoring of anti-tumor therapies and detection of recurrence reduce the treatment effectiveness of current strategies for 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. The study is undertaken to explore SEMA4C's potential role as an early relapse biomarker in breast cancer.

Eligibility criteria: Inclusion Criteria:

* Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery

Exclusion Criteria:

* Patients who are not mentally capable of giving written informed consent
* Serum samples doesn't qualified
* Patients who refuse follow-up on their conditions
* Patients with prior cancer history
* Patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study

Primary outcomes:
measure: diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer
timeFrame: 5 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
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.