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

NCT04540224 | Completed DMC

• 1 other identifier: Breast Cancer
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Luminal A; Luminal B; Triple Negative; Cytokine; Flow-Cytometry

Outcome Measures

Primary Outcomes (1)

• Serum cytokine levels

  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

  6 months

Study Arms (4)

Luminal A

Breast cancer patients with Luminal A phenotype

Diagnostic Test: Flow-Cytometric analysis

Luminal B

Breast cancer patients with Luminal B phenotype

Diagnostic Test: Flow-Cytometric analysis

Triple Negative

Breast cancer patients with Triple negative phenotype

Diagnostic Test: Flow-Cytometric analysis

Control

Healthy volunteers

Diagnostic Test: Flow-Cytometric analysis

Interventions

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

Control; Luminal A; Luminal B; Triple Negative

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: We want to evaluate the cytokine levels of female breast cancers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

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

  PMID: 30340457 BACKGROUND

• 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.

  PMID: 32074342 BACKGROUND

• 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 Jun;130:155079. doi: 10.1016/j.cyto.2020.155079. Epub 2020 Mar 28.

  PMID: 32229413 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ufuk Oguz Idiz, Assoc.Prof.

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 7, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

TU (1)