SEMA4C as a Relapse Biomarker in Breast Cancer

NCT03663153 | Not Yet Recruiting

• 1 other identifier: 2018-TJ-BCP
• Study Type: observational
• Target: 4,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer

  Analyze the sensitivity, specificity, positive predictive value, negative predictive value, accuracy of SEMA4C in predicting recurrence of breast cancer

  5 years

Secondary Outcomes (1)

• Disease Free Survival

  5 years

Study Arms (2)

SEMA4C high value follow-up group

Postoperative SEMA4C value is higher than 5.00 ng/ml.

Other: SEMA4C high value follow-up group

SEMA4C low value follow-up group

Postoperative SEMA4C value is lower than 5.00 ng/ml.

Other: SEMA4C low value follow-up group

Interventions

SEMA4C high value follow-up group OTHER

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 high value follow-up group

SEMA4C low value follow-up group OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Hubei Cancer Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Wuhan Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• The First People's Hospital of Jingzhou: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

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: 27401250 BACKGROUND

• 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: 29555978 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qinglei Gao, MD, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglei Gao, MD, PhD

CONTACT

13871127473; qingleigao@hotmail.com

Ding Ma, MD, PhD

CONTACT

13886090620; dingma424@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• 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 10, 2018
• Study Start: September 1, 2022
• Primary Completion: August 1, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 7, 2021

Record last verified: 2021-10