Clinical trial NCT04540224: The Relationship Between the Differences in Blood Cytokine Values in Breast Cancers.
Official title: The Relationship Between the Differences in Blood Cytokine Values and Disease Stage in Luminal A, Luminal B and Triple Negative Breast Cancers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Luminal A
Luminal B
Triple Negative
Cytokine
Flow-Cytometry
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-07
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In case group patients with breast cancers will be included to the study. Patients will be divided into subgroups according to the cancer receptor status.

Also healty volunteers who don't have breast compliants will be the control group

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer

Exclusion Criteria:

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

Primary outcomes:
measure: Serum cytokine levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Ufuk Oguz Idiz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murata M. Inflammation and cancer. Environ Health Prev Med. 2018 Oct 20;23(1):50. doi: 10.1186/s12199-018-0740-1.
citation: 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.
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 (TGFbeta1) 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. Online ahead of print.