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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540224
• Other study ID #: Breast Cancer
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2022
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with breast cancer

Exclusion Criteria:

• Cancer Patients other than breast cancers

• Patients with known immunodeficiency

• Pregnancy

• Patients who had neoadjuvant chemoradiotherapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Flow-Cytometric analysis
Measuring the level of serum IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bera A, Russ E, Manoharan MS, Eidelman O, Eklund M, Hueman M, Pollard HB, Hu H, Shriver CD, Srivastava M. Proteomic Analysis of Inflammatory Biomarkers Associated With Breast Cancer Recurrence. Mil Med. 2020 Jan 7;185(Suppl 1):669-675. doi: 10.1093/milmed/usz254. Erratum in: Mil Med. 2020 Sep 18;185(9-10):e1901. Srinivasan, Muthu [corrected to Manoharan, Muthu Saravanan]. — View Citation

Murata M. Inflammation and cancer. Environ Health Prev Med. 2018 Oct 20;23(1):50. doi: 10.1186/s12199-018-0740-1. Review. — View Citation

Vitiello GAF, Amarante MK, Oda JMM, Hirata BKB, de Oliveira CEC, Campos CZ, de Oliveira KB, Guembarovski RL, Watanabe MAE. Transforming growth factor beta 1 (TGFß1) plasmatic levels in breast cancer and neoplasia-free women: Association with patients' characteristics and TGFB1 haplotypes. Cytokine. 2020 Mar 28;130:155079. doi: 10.1016/j.cyto.2020.155079. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cytokine levels	Serum Levels of serum IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33	6 months