Diagnosis Value of SEMA4C in Breast Cancer

Sponsor
Tongji Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03662633
Collaborator
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)
2,300
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Breast cancer group
  • Diagnostic Test: Benign breast tumor group

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Diagnosis Value of SEMA4C in Breast Cancer
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Breast cancer group

Patients who have histologically confirmed new diagnosis of breast cancer are recruited.

Diagnostic Test: Breast 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.

Benign breast tumor group

Patients who have histologically confirmed new diagnosis of benign breast tumors are recruited.

Diagnostic Test: Benign 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.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic potential of SEMA4C as a biomarker for breast cancer [At the time of inclusion]

    Analyzing the predictive value of SEMA4C in the diagnosis of breast cancer.

Secondary Outcome Measures

  1. Serum SEMA4C, Mammography, breast US and MRI in comparison and combination to distinguish breast cancer from benign breast tumor [At the time of inclusion]

    Compare and combine the diagnostic performances of Serum SEMA4C, traditional mammography, ultrasonography, and contrast-enhanced MR imaging in the assessment of breast cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Qinglei Gao, MD, PhD, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qinglei Gao, Clinical Professor, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT03662633
Other Study ID Numbers:
  • 2018-TJ-BCD
First Posted:
Sep 7, 2018
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021