NCT03662633

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
5 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

September 3, 2018

Last Update Submit

October 18, 2022

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

  • Diagnostic potential of SEMA4C as a biomarker for breast cancer

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

    At the time of inclusion

Secondary Outcomes (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

Study Arms (2)

Breast cancer group

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

Diagnostic Test: Breast cancer group

Benign breast tumor group

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

Diagnostic Test: Benign breast tumor group

Interventions

Breast cancer groupDIAGNOSTIC_TEST

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.

Breast cancer group
Benign breast tumor groupDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Receiving no treatment before diagnosis
  • Establishing Diagnosis according to biopsy or surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wei JC, Yang J, Liu D, Wu MF, Qiao L, Wang JN, Ma QF, Zeng Z, Ye SM, Guo ES, Jiang XF, You LY, Chen Y, Zhou L, Huang XY, Zhu T, Meng L, Zhou JF, Feng ZH, Ma D, Gao QL. Tumor-associated Lymphatic Endothelial Cells Promote Lymphatic Metastasis By Highly Expressing and Secreting SEMA4C. Clin Cancer Res. 2017 Jan 1;23(1):214-224. doi: 10.1158/1078-0432.CCR-16-0741. Epub 2016 Jul 8.

    PMID: 27401250BACKGROUND

  • Gurrapu S, Pupo E, Franzolin G, Lanzetti L, Tamagnone L. Sema4C/PlexinB2 signaling controls breast cancer cell growth, hormonal dependence and tumorigenic potential. Cell Death Differ. 2018 Jul;25(7):1259-1275. doi: 10.1038/s41418-018-0097-4. Epub 2018 Mar 19.

    PMID: 29555978BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

  • Qinglei Gao, MD, PhD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglei Gao, MD, PhD

CONTACT

13871127473qingleigao@hotmail.com

Ding Ma, MD, PhD

CONTACT

13886090620dingma424@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 7, 2018

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

October 20, 2022

Record last verified: 2022-10