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SEMA4C as a Relapse Biomarker 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: NCT03663153
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
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

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Other: SEMA4C high value follow-up group Other: SEMA4C low value follow-up 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. 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 Design
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Study Type : Observational
Estimated Enrollment : 4200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: SEMA4C as a Relapse Biomarker in Breast Cancer
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
SEMA4C high value follow-up group
Postoperative SEMA4C value is higher than 5.00 ng/ml.
 Other: 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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Value of SEMA4C in predicting recurrence of breast cancer [ Time Frame: 5 years ]
    Analyze the sensitivity, specificity, positive predictive value, negative predictive value, accuracy of SEMA4C in predicting recurrence of breast cancer


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 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.

  2. Questionnaire about Quality of Life [ Time Frame: 5 years ]
    Evaluate the quality of life during follow-up through questionnaires


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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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 breast cancer. All cases were confirmed histopathologically according to the WHO Classification of Tumors.
Criteria

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
Contacts and Locations
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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): NCT03663153


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
More Information
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Publications:

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Responsible Party: Qinglei Gao, Clinical Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03663153    
Other Study ID Numbers: 2018-TJ-BCP
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
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