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Completed

NCT Number: NCT04540224

The Relationship Between the Differences in Blood Cytokine Values in Breast Cancers.

While classification of malignant breast tumors has traditionally been made according to their histological appearance, nowadays some subtypes have been defined according to their molecular features. The different behaviors of tumors in the luminal group necessitated the need to separate this group into luminal A and B subtypes. Luminal A group has the highest prevalence among breast cancers; It includes Her2 negative tumors with low proliferative activity, mitosis rate and low histological grade. The prognosis of patients with luminal A tumors is very good and metastases are often limited to bones. Luminal-B tumors are more aggressive. There are some studies investigating the relationship between blood cytokine levels (TGFβ1, IFNγ) and breast cancer. Human studies have generally evaluated a limited number of cytokines. The study evaluating the largest number of different cytokines was an animal study, and 24 different cytokine levels were compared with healthy control rats with breast cancer. Our aim in this study is to evaluate the relationship between the differences in blood cytokine values and disease stage in Luminal A, Luminal B, and triple negative breast cancers.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

Breast cancer is the most common type of cancer in women and the second most common cause of death after lung cancer. In epidemiological studies, its prevalence is 22-26%, and the risk of mortality due to breast cancer is around 18%. While classification of malignant breast tumors has traditionally been made according to their histological appearance, nowadays some subtypes have been defined according to their molecular features. The different behaviors of tumors in the luminal group necessitated the need to separate this group into luminal A and B subtypes. Luminal A group has the highest prevalence among breast cancers; It includes Her2 negative tumors with low proliferative activity, mitosis rate and low histological grade. The prognosis of patients with luminal A tumors is very good and metastases are often limited to bones. Luminal-B tumors are more aggressive. The most important difference of this group is that tumors have a high proliferation rate. The breakpoint between Luminal A and B is generally accepted immunohistochemically as less than 14% of tumor cells show nuclear Ki67 expression. In addition, approximately 30% of Her2 positive tumors are immunohistochemically in the luminal B phenotype.

Infection and inflammation constitute approximately 25% of the causes of cancer.Cancers associated with inflammation usually occur as a result of mutations in DNA. Examples of cancers associated with chronic infections include Schistosoma haematobium-bladder cancer, Helicobacter pylori-stomach cancer, human papillomavirus-cervical cancer, Epstein-Barr virus-nasopharynx cancer, while chronic inflammation due to pro-inflammatory factors (asbestos, nanomaterials, Barrett's esophagus and ulcerative colitis etc.) plays a role in cancer development. Chronic inflammation also plays an important role in the development and recurrence of breast cancer. NF-κB pathway proteins, CRP, serum amyloid, matrix metalloproteinase enzyme family (MMP2, MMP9), urokinase type tissue plasminogen activators are associated with inflammatory cell migration and breast cancer.

There are some studies investigating the relationship between blood cytokine levels (TGFβ1, IFNγ) and breast cancer. Human studies have generally evaluated a limited number of cytokines. The study evaluating the largest number of different cytokines was an animal study, and 24 different cytokine levels were compared with healthy control rats with breast cancer.In this study we aimed to evaluate the relationship between the differences in blood cytokine values (IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33) and disease stage in Luminal A, Luminal B, and triple negative breast cancers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with breast cancer

Exclusion criteria

  • Cancer Patients other than breast cancers
  • Patients with known immunodeficiency
  • Pregnancy
  • Patients who had neoadjuvant chemoradiotherapy

Treatment and study plan

Flow-cytometric analysis

Diagnostic Test

Measuring the level of serum IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33

Primary outcomes

  1. Serum cytokine levels

    Time frame: 6 months

    Serum Levels of serum IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

The Relationship Between the Differences in Blood Cytokine Values and Disease Stage in Luminal A, Luminal B and Triple Negative Breast Cancers.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 7, 2020
Registry last updated
Aug 9, 2022

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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