SEMA4C as a Relapse Biomarker in Breast Cancer

Sponsor
Tongji Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03663153
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)
4,200
Enrollment
47
Anticipated Duration (Months)

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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

Study Type:
Observational
Anticipated Enrollment :
4200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
SEMA4C as a Relapse Biomarker in Breast Cancer
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

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:
NCT03663153
Other Study ID Numbers:
  • 2018-TJ-BCP
First Posted:
Sep 10, 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