Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
4200 participants
OBSERVATIONAL
2022-09-01
2026-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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SEMA4C high value follow-up group
Postoperative SEMA4C value is higher than 5.00 ng/ml.
SEMA4C high value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
SEMA4C low value follow-up group
Postoperative SEMA4C value is lower than 5.00 ng/ml.
SEMA4C low value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
Interventions
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SEMA4C high value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
SEMA4C low value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Hubei Cancer Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Wuhan Central Hospital
OTHER
Xiangyang Central Hospital
OTHER
The First People's Hospital of Jingzhou
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Tongji Hospital
OTHER
Responsible Party
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Qinglei Gao
Clinical Professor
Principal Investigators
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Qinglei Gao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Central Contacts
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References
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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.
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.
Other Identifiers
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2018-TJ-BCP
Identifier Type: -
Identifier Source: org_study_id
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