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Diagnosis Value of SEMA4C in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662633
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Qinglei Gao, Tongji Hospital

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
Breast Neoplasm Female 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.

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Study Type : Observational
Estimated Enrollment : 2300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnosis Value of SEMA4C in Breast Cancer
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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.




Primary Outcome Measures :
  1. Diagnostic potential of SEMA4C as a biomarker for breast cancer [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants including patients with benign breast tumors and patients with breast cancer. All cases were confirmed histopathologically according to the WHO Classification of Tumors.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662633


Contacts
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Contact: Qinglei Gao, MD, PhD 13871127473 qingleigao@hotmail.com
Contact: Ding Ma, MD, PhD 13886090620 dingma424@126.com

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
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Principal Investigator: Qinglei Gao, MD, PhD Tongji Hospital
Publications:
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Responsible Party: Qinglei Gao, Clinical Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03662633    
Other Study ID Numbers: 2018-TJ-BCD
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases