Breast CancerNCT04540224
The Relationship Between the Differences in Blood Cytokine Values in Breast Cancers.
An observational study of Breast Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Flow-Cytometric analysis
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with breast cancer
Who cannot join
- Cancer Patients other than breast cancers
- Patients with known immunodeficiency
- Pregnancy
- Patients who had neoadjuvant chemoradiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34371
About this study
Official title: The Relationship Between the Differences in Blood Cytokine Values and Disease Stage in Luminal A, Luminal B and Triple Negative 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Flow-Cytometric analysis
- Keywords
- Luminal A, Luminal B, Triple Negative, Cytokine, Flow-Cytometry
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-Cytometric analysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Luminal A | Breast cancer patients with Luminal A phenotype Receives: Diagnostic Test: Flow-Cytometric analysis | |
| Luminal B | Breast cancer patients with Luminal B phenotype Receives: Diagnostic Test: Flow-Cytometric analysis | |
| Triple Negative | Breast cancer patients with Triple negative phenotype Receives: Diagnostic Test: Flow-Cytometric analysis | |
| Control | Healthy volunteers Receives: Diagnostic Test: Flow-Cytometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
- Investigators
- Ufuk Oguz Idiz, Assoc.Prof., Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540224
- Sponsor's protocol ID
- Breast Cancer
- Status last verified
- Aug 2022
- First submitted
- 3 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murata M. Inflammation and cancer. Environ Health Prev Med. 2018 Oct 20;23(1):50. doi: 10.1186/s12199-018-0740-1.
PubMed 30340457Bera 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.
PubMed 32074342Vitiello 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.
PubMed 32229413
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Differences in Blood Cytokine Values and Disease Stage in Luminal A, Luminal B and Triple Negative Breast Cancers.
- ClinicalTrials.gov ID
- NCT04540224
- Acronym / sponsor ID
- Breast Cancer
- Conditions
- Breast Cancer
- Keywords
- Luminal A, Luminal B, Triple Negative, Cytokine, Flow-Cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Luminal A | – | Diagnostic Test: Flow-Cytometric analysisBreast cancer patients with Luminal A phenotype |
| Luminal B | – | Diagnostic Test: Flow-Cytometric analysisBreast cancer patients with Luminal B phenotype |
| Triple Negative | – | Diagnostic Test: Flow-Cytometric analysisBreast cancer patients with Triple negative phenotype |
| Control | – | Diagnostic Test: Flow-Cytometric analysisHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with breast cancer
Key exclusion criteria (4 listed)
- Cancer Patients other than breast cancers
- Patients with known immunodeficiency
- Pregnancy
- Patients who had neoadjuvant chemoradiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow-Cytometric analysisMeasuring 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 | Diagnostic test | Control, Luminal A, Luminal B, Triple Negative |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 30340457Murata M. Inflammation and cancer. Environ Health Prev Med. 2018 Oct 20;23(1):50. doi: 10.1186/s12199-018-0740-1.
- Background: PubMed 32074342Bera 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.
- Background: PubMed 32229413Vitiello 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ufuk Oguz Idiz, Assoc.Prof. principal investigator
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cytokine levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540224, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.