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NCT Number: NCT03663153

SEMA4C as a Relapse Biomarker in Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive 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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ding Ma, MD, PhD

CONTACT

[email protected]

13886090620

Qinglei Gao, MD, PhD

CONTACT

[email protected]

13871127473

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Sep 10, 2018
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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