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Diagnosis Value of SEMA4C in Breast Cancer

Diagnosis Value of SEMA4C in Breast Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03662633
Enrollment
2300
Registered
2018-09-07
Start date
2023-09-01
Completion date
2024-09-01
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Female

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.

Interventions

DIAGNOSTIC_TESTBreast 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.

DIAGNOSTIC_TESTBenign 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.

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic potential of SEMA4C as a biomarker for breast cancerAt the time of inclusionAnalyzing the predictive value of SEMA4C in the diagnosis of breast cancer.

Secondary

MeasureTime frameDescription
Serum SEMA4C, Mammography, breast US and MRI in comparison and combination to distinguish breast cancer from benign breast tumorAt the time of inclusionCompare and combine the diagnostic performances of Serum SEMA4C, traditional mammography, ultrasonography, and contrast-enhanced MR imaging in the assessment of breast cancer

Contacts

Primary ContactQinglei Gao, MD, PhD
qingleigao@hotmail.com13871127473
Backup ContactDing Ma, MD, PhD
dingma424@126.com13886090620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026