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SEMA4C as a Relapse Biomarker in Breast Cancer

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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

Tracking Information
First Submitted Date September 3, 2018
First Posted Date September 10, 2018
Last Update Posted Date September 10, 2018
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 5, 2018)
  • 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.
  • Questionnaire about Quality of Life [ Time Frame: 5 years ]
    Evaluate the quality of life during follow-up through questionnaires
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SEMA4C as a Relapse Biomarker in Breast Cancer
Official Title SEMA4C as a Relapse Biomarker in Breast Cancer
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
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.
Condition Breast Cancer
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • SEMA4C high value follow-up group
    Postoperative SEMA4C value is higher than 5.00 ng/ml.
    Intervention: Other: SEMA4C high value follow-up group
  • SEMA4C low value follow-up group
    Postoperative SEMA4C value is lower than 5.00 ng/ml.
    Intervention: Other: SEMA4C low value follow-up group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 5, 2018)
4200
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2026
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Qinglei Gao, MD, PhD 13871127473 qingleigao@hotmail.com
Contact: Ding Ma, MD, PhD 13886090620 dingma424@126.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03663153
Other Study ID Numbers 2018-TJ-BCP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Qinglei Gao, Tongji Hospital
Study Sponsor Tongji Hospital
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
Investigators
Principal Investigator: Qinglei Gao, MD, PhD Tongji Hospital
PRS Account Tongji Hospital
Verification Date September 2018