SEMA4C as a Relapse Biomarker in Breast Cancer

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Other: SEMA4C low value follow-up group; Other: SEMA4C high value follow-up group

• Registration Number: NCT03663153
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Study Start: 2022-09-01
• Primary Completion: 2023-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SEMA4C low value follow-up group	SEMA4C low value follow-up group	Postoperative SEMA4C value is lower than 5.00 ng/ml.
SEMA4C high value follow-up group	SEMA4C high value follow-up group	Postoperative SEMA4C value is higher than 5.00 ng/ml.

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer	5 years	Analyze the sensitivity, specificity, positive predictive value, negative predictive value, accuracy of SEMA4C in predicting recurrence of breast cancer

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	5 years	Disease Free Survival (DFS) can be determined according to clinical practice based on any of the following: applicable imaging technique, biopsy and surgery.