Breast CancerNCT04729647
Immature Granulocyte Count and Delta Neutrophil Index Factors for Axillary Metastasis of Breast Cancer
A study testing Mastectomy in people with Breast Cancer and Breast Cancer Invasive, run by Kahramanmaras Sutcu Imam University.
Trial summary
Background: Breast cancer ranks first among cancer types seen in women in our country and all over the world, and second after lung cancer in cancer-related deaths. Despite the recent increase in its incidence, mortality has decreased due to early diagnosis and advances in neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Invasive
- What is being tested?
- Mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2020
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, mixed invasive ductal lobular carcinoma, mucinous carcinoma, medullary carcinoma, micropapillary carcinoma)
- Clinically negative axillarry metastasis(without neoadjuvant chemotherapy/radiotherapy)
- Pathologically positive or negative axillary metastasis
- No missing data.
Who cannot join
- Patients who underwent surgery for benign breast disease (such as fibroadenomas, garnulomatous mastitis, hamartomas)
- Patients with other breast malignancies other than invasive breast carcinoma (ductal carcinoma in situ, fibrosarcomas, neuroendocrine tumors, myofibroblastomas, phyllodes tumors)
- Clinically preoperative positive axillary metastasis
- Preoperative patients with distant organ metastasis
- Patients who received neoadjuvant chemotherapy / radiotherapy in the preoperative period
- Patients with missing data
About this study
Official title: Immature Granulocyte Count and Delta Neutrophil Index as New Predictive Factors for Axillary Metastasis of Breast Cancer
Background: Breast cancer ranks first among cancer types seen in women in our country and all over the world, and second after lung cancer in cancer-related deaths. Despite the recent increase in its incidence, mortality has decreased due to early diagnosis and advances in neoadjuvant therapy. Classically, lymph node status, tumor size, histological type and grade, age, and ethnicity are prognostic factors for this type of cancer. Bone marrow activation results from malignancies and inflammation. Tumor-related inflammation has gained importance in each stage of tumorigenesis. Host-dependent systemic inflammatory response has been found to be effective in carcinogenesis, tumor development and progression. Inadequately controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Inflammatory cell stimulation occurs in lymph node metastasis and distant organ metastases like primary tumor.As the cornerstone of the adaptive immune system, lymphocytes inhibit tumor cell proliferation, migration and destroy metastatic lesions. Monocyte-macrophages inhibit angiogenesis, tumor growth and distant spread. On the other hand, tumor-induced neutrophils can accelerate tumor metastasis. Many studies have examined the relationship between the ratios between different cell types, such as the platelet-lymphocyte ratio (PLR), and the neutrophil-lymphocyte ratio (NLR), with malignant tumors(4,10).Apart from these, mean platelet volume (MPV), which can be automatically studied in routine blood counts and shows platelet activation, has been used to show tumor activity in breast, stomach, colon and ovarian cancers.
Recent studies have identified the delta neutrophil index (DNI), which indicates the percentage of immature granulocytes (IG) in peripheral blood due to increased bone marrow activation in inflammatory conditions.It is based on counting granulocyte precursor cells under microscope. With the technological developments,IG count and DNI can be automatically evaluated from complete blood count parameters in automated systems.
Read more
In this study,the investigators aimed to determine the diagnostic value of preoperative IG number and DNI level before clinical detection of axillary lymph node metastasis, which plays an important role in the prognosis of breast cancer, and to compare these parameters with other routine inflammation markers such as white blood cell count (WBC), MPV, NLR and PLR.
Material - Methods:Patients who were older than eighteen and operated for breast pathology in Kahramanmaras Sutcu Imam University,Department of General Surgery between February 2015 and February 2020 were evaluated retrospectively.Patient data were obtained from patient epicrisis forms and preoperative laboratory and postoperative pathology results recorded in the computer system.Demographic data of the patients,routine blood tests,preoperative imaging methods, preoperative tumor size,presence of axillary lymph node metastasis and distant organ metastasis,presence of pathological axillary lymph node metastasis in the postoperative period were evaluated.
In the preoperative period, patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic(Group NM) and metastasized(Group M) in axillary lymph node sampling.
White blood cell(WBC)count,neutrophil count,lymphocyte count,platelet count,mean platelet volume(MPV),IG count and DNI(IG percentage)were measured using an automated hematological analyzer from blood samples obtained at the preoperative previous month of surgery.Neutrophil to lymhpocyte ratio(NLR) and platelet to lymphocyte ratio(PLR) were manually calculated from the complete blood cell results.
Read the detailed description
Background: Breast cancer ranks first among cancer types seen in women in our country and all over the world, and second after lung cancer in cancer-related deaths. Despite the recent increase in its incidence, mortality has decreased due to early diagnosis and advances in neoadjuvant therapy. Classically, lymph node status, tumor size, histological type and grade, age, and ethnicity are prognostic factors for this type of cancer. Bone marrow activation results from malignancies and inflammation. Tumor-related inflammation has gained importance in each stage of tumorigenesis. Host-dependent systemic inflammatory response has been found to be effective in carcinogenesis, tumor development and progression. Inadequately controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Inflammatory cell stimulation occurs in lymph node metastasis and distant organ metastases like primary tumor.As the cornerstone of the adaptive immune system, lymphocytes inhibit tumor cell proliferation, migration and destroy metastatic lesions. Monocyte-macrophages inhibit angiogenesis, tumor growth and distant spread. On the other hand, tumor-induced neutrophils can accelerate tumor metastasis. Many studies have examined the relationship between the ratios between different cell types, such as the platelet-lymphocyte ratio (PLR), and the neutrophil-lymphocyte ratio (NLR), with malignant tumors.Apart from these, mean platelet volume (MPV), which can be automatically studied in routine blood counts and shows platelet activation, has been used to show tumor activity in breast, stomach, colon and ovarian cancers.
Recent studies have identified the delta neutrophil index (DNI), which indicates the percentage of immature granulocytes (IG) in peripheral blood due to increased bone marrow activation in inflammatory conditions.It is based on counting granulocyte precursor cells under microscope. With the technological developments,IG count and DNI can be automatically evaluated from complete blood count parameters in automated systems.
In this study, investigators aimed to determine the diagnostic value of preoperative IG number and DNI level before clinical detection of axillary lymph node metastasis, which plays an important role in the prognosis of breast cancer, and to compare these parameters with other routine inflammation markers such as white blood cell count (WBC), MPV, NLR and PLR.
Material - Methods:Patients who were older than eighteen and operated for breast pathology in Kahramanmaras Sutcu Imam University,Department of General Surgery between February 2015 and February 2020 were evaluated retrospectively.Patient data were obtained from patient epicrisis forms and preoperative laboratory and postoperative pathology results recorded in the computer system.Demographic data of the patients,routine blood tests,preoperative imaging methods, preoperative tumor size,presence of axillary lymph node metastasis and distant organ metastasis,presence of pathological axillary lymph node metastasis in the postoperative period were evaluated.
In the preoperative period, patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic(Group NM) and metastasized(Group M) in axillary lymph node sampling.
White blood cell(WBC)count,neutrophil count,lymphocyte count,platelet count,mean platelet volume(MPV),IG count and DNI(IG percentage)were measured using an automated hematological analyzer from blood samples obtained at the preoperative previous month of surgery.Neutrophil to lymhpocyte ratio(NLR) and platelet to lymphocyte ratio(PLR) were manually calculated from the complete blood cell results.
Statistical Evaluation:IBM-Statistical Package for Social Sciences (SPSS) version 20 was used for statistical analysis. In the evaluation between independent groups;normal distribution was checked for the kolmogorov-simirnov test.While student t test or Mann Whitney U test was used in the evaluation of numerical data according to the conformity of the data to normal distribution,chi-square test was used in the evaluation of categorical data.Multivariate analysis was performed with parameters found to be significant in the evaluation of univariate analysis and predictive values of preoperative blood parameters were calculated.ROC analysis was performed to evaluate the effectiveness of WBC, NLR, PLR, DNI, IG number and MPV values,and sensitivity,specificity values and cut-off values were obtained. Numerical values are expressed as median(minimum - maximum values), categorical values as percentage (%).
- Conditions
- Breast Cancer, Breast Cancer Invasive
- Being tested
- Mastectomy
- Keywords
- Delta Neutrophil Index, Immature Granulocyte Count, Netrophil Lymphocyte Ratio, Breast Cancer, Axillary Metastasis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Also called Sentinel Lymph Node, Axillary dissection, Complete Blood Count, Delta Neutrophil Index
Mastectomy for breast cancer Blood sample for Complete Blood Cell Count and other blood parameters (Delta Neutrophil Index, Immature Granulocyte Count)
| Study group | Role | What they receive |
|---|---|---|
| Axillary Lymph Node Metastasis | Other | Not described Receives: Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of preoperative axillary metastasis in clinically negative patients
DNI and IG count calculated automatically in blood samples of the preoperative period of the invasive breast cancer patients
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startFeb 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic (Group NM) and metastasized (Group M) in axillary lymph node sampling.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729647
- Sponsor's protocol ID
- 19
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koc Z, Saglam Z. Determination of the Knowledge and the Practice of Female Patients about breast cancer, Preventive Measures and Breast Self Examination and Effectiveness of Education. Eur J Breast Heal. 2009;5(1):25-33.
Marin Hernandez C, Pinero Madrona A, Gil Vazquez PJ, Galindo Fernandez PJ, Ruiz Merino G, Alonso Romero JL, Parrilla Paricio P. Usefulness of lymphocyte-to-monocyte, neutrophil-to-monocyte and neutrophil-to-lymphocyte ratios as prognostic markers in breast cancer patients treated with neoadjuvant chemotherapy. Clin Transl Oncol. 2018 Apr;20(4):476-483. doi: 10.1007/s12094-017-1732-0. Epub 2017 Aug 7.
PubMed 28785911DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2.
PubMed 31577379Peng Y, Chen R, Qu F, Ye Y, Fu Y, Tang Z, Wang Y, Zong B, Yu H, Luo F, Liu S. Low pretreatment lymphocyte/monocyte ratio is associated with the better efficacy of neoadjuvant chemotherapy in breast cancer patients. Cancer Biol Ther. 2020;21(2):189-196. doi: 10.1080/15384047.2019.1680057. Epub 2019 Nov 4.
PubMed 31684807Miklikova S, Minarik G, Sedlackova T, Plava J, Cihova M, Jurisova S, Kalavska K, Karaba M, Benca J, Smolkova B, Mego M. Inflammation-Based Scores Increase the Prognostic Value of Circulating Tumor Cells in Primary Breast Cancer. Cancers (Basel). 2020 May 1;12(5):1134. doi: 10.3390/cancers12051134.
PubMed 32369910Elyasinia F, Keramati MR, Ahmadi F, Rezaei S, Ashouri M, Parsaei R, Yaghoubi M, Elyasinia F, Aboutorabi A, Kaviani A. Neutrophil-Lymphocyte Ratio in Different Stages of Breast Cancer. Acta Med Iran. 2017 Apr;55(4):228-232.
PubMed 28532133Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.
PubMed 17443564Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
PubMed 33067685Singh R, Mishra MK, Aggarwal H. Inflammation, Immunity, and Cancer. Mediators Inflamm. 2017;2017:6027305. doi: 10.1155/2017/6027305. Epub 2017 Nov 6. No abstract available.
PubMed 29234189Ibrahim A, Serkan YF, Tuba A, Erol B, Lutfi P. Can Neutrophil to Lymphocyte Ratio Be a Predictor Tool for The Non-Sentinel Lymph Node Metastasis in Breast Cancer? Chirurgia (Bucur). 2019 Jan-Feb;114(1):83-88. doi: 10.21614/chirurgia.114.1.83.
PubMed 30830848Taskaynatan H, Alacacioglu A, Kucukzeybek Y, Varol U, Yildiz Y, Salman T, Oflazoglu U, Tarhan MO. Is Monitoring Mean Platelet Volume Necessary in Breast Cancer Patients? Open Med (Wars). 2018 Oct 4;13:450-455. doi: 10.1515/med-2018-0067. eCollection 2018.
PubMed 30426082Li MM, Yue CX, Fu S, Zhang X, Zhao CJ, Wang RT. Platelet Volume Is Reduced In Metastasing Breast Cancer: Blood Profiles Reveal Significant Shifts. Cancer Manag Res. 2019 Oct 24;11:9067-9072. doi: 10.2147/CMAR.S221976. eCollection 2019.
PubMed 31695497Song Y, Yang Y, Gao P, Chen X, Yu D, Xu Y, Zhao J, Wang Z. The preoperative neutrophil to lymphocyte ratio is a superior indicator of prognosis compared with other inflammatory biomarkers in resectable colorectal cancer. BMC Cancer. 2017 Nov 10;17(1):744. doi: 10.1186/s12885-017-3752-0.
PubMed 29126400Barut O, Demirkol MK, Bilecan EB, Sahinkanat T, Resim S. The Delta Neutrophil Index is an Early Predictive Marker of Acute Pyelonephritis in Patients with Ureteral Stone. J Coll Physicians Surg Pak. 2020 Nov;30(11):1149-1154. doi: 10.29271/jcpsp.2020.11.1149.
PubMed 33222730De Giorgi U, Mego M, Scarpi E, Giordano A, Giuliano M, Valero V, Alvarez RH, Ueno NT, Cristofanilli M, Reuben JM. Association between circulating tumor cells and peripheral blood monocytes in metastatic breast cancer. Ther Adv Med Oncol. 2019 Aug 14;11:1758835919866065. doi: 10.1177/1758835919866065. eCollection 2019.
PubMed 31452692
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immature Granulocyte Count and Delta Neutrophil Index as New Predictive Factors for Axillary Metastasis of Breast Cancer
- ClinicalTrials.gov ID
- NCT04729647
- Acronym / sponsor ID
- 19
- Conditions
- Breast Cancer, Breast Cancer Invasive
- Keywords
- Delta Neutrophil Index, Immature Granulocyte Count, Netrophil Lymphocyte Ratio, Breast Cancer, Axillary Metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 28 Jan 2021 (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.
Background: Breast cancer ranks first among cancer types seen in women in our country and all over the world, and second after lung cancer in cancer-related deaths. Despite the recent increase in its incidence, mortality has decreased due to early diagnosis and advances in neoadjuvant therapy. Classically, lymph node status, tumor size, histological type and grade, age, and ethnicity are prognostic factors for this type of cancer. Bone marrow activation results from malignancies and inflammation. Tumor-related inflammation has gained importance in each stage of tumorigenesis. Host-dependent systemic inflammatory response has been found to be effective in carcinogenesis, tumor development and progression. Inadequately controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Inflammatory cell stimulation occurs in lymph node metastasis and distant organ metastases like primary tumor.As the cornerstone of the adaptive immune system, lymphocytes inhibit tumor cell proliferation, migration and destroy metastatic lesions. Monocyte-macrophages inhibit angiogenesis, tumor growth and distant spread. On the other hand, tumor-induced neutrophils can accelerate tumor metastasis. Many studies have examined the relationship between the ratios between different cell types, such as the platelet-lymphocyte ratio (PLR), and the neutrophil-lymphocyte ratio (NLR), with malignant tumors(4,10).Apart from these, mean platelet volume (MPV), which can be automatically studied in routine blood counts and shows platelet activation, has been used to show tumor activity in breast, stomach, colon and ovarian cancers.
Recent studies have identified the delta neutrophil index (DNI), which indicates the percentage of immature granulocytes (IG) in peripheral blood due to increased bone marrow activation in inflammatory conditions.It is based on counting granulocyte precursor cells under microscope. With the technological developments,IG count and DNI can be automatically evaluated from complete blood count parameters in automated systems.
In this study,the investigators aimed to determine the diagnostic value of preoperative IG number and DNI level before clinical detection of axillary lymph node metastasis, which plays an important role in the prognosis of breast cancer, and to compare these parameters with other routine inflammation markers such as white blood cell count (WBC), MPV, NLR and PLR.
Material - Methods:Patients who were older than eighteen and operated for breast pathology in Kahramanmaras Sutcu Imam University,Department of General Surgery between February 2015 and February 2020 were evaluated retrospectively.Patient data were obtained from patient epicrisis forms and preoperative laboratory and postoperative pathology results recorded in the computer system.Demographic data of the patients,routine blood tests,preoperative imaging methods, preoperative tumor size,presence of axillary lymph node metastasis and distant organ metastasis,presence of pathological axillary lymph node metastasis in the postoperative period were evaluated.
In the preoperative period, patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic(Group NM) and metastasized(Group M) in axillary lymph node sampling.
White blood cell(WBC)count,neutrophil count,lymphocyte count,platelet count,mean platelet volume(MPV),IG count and DNI(IG percentage)were measured using an automated hematological analyzer from blood samples obtained at the preoperative previous month of surgery.Neutrophil to lymhpocyte ratio(NLR) and platelet to lymphocyte ratio(PLR) were manually calculated from the complete blood cell results.
Detailed description
Background: Breast cancer ranks first among cancer types seen in women in our country and all over the world, and second after lung cancer in cancer-related deaths. Despite the recent increase in its incidence, mortality has decreased due to early diagnosis and advances in neoadjuvant therapy. Classically, lymph node status, tumor size, histological type and grade, age, and ethnicity are prognostic factors for this type of cancer. Bone marrow activation results from malignancies and inflammation. Tumor-related inflammation has gained importance in each stage of tumorigenesis. Host-dependent systemic inflammatory response has been found to be effective in carcinogenesis, tumor development and progression. Inadequately controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Inflammatory cell stimulation occurs in lymph node metastasis and distant organ metastases like primary tumor.As the cornerstone of the adaptive immune system, lymphocytes inhibit tumor cell proliferation, migration and destroy metastatic lesions. Monocyte-macrophages inhibit angiogenesis, tumor growth and distant spread. On the other hand, tumor-induced neutrophils can accelerate tumor metastasis. Many studies have examined the relationship between the ratios between different cell types, such as the platelet-lymphocyte ratio (PLR), and the neutrophil-lymphocyte ratio (NLR), with malignant tumors.Apart from these, mean platelet volume (MPV), which can be automatically studied in routine blood counts and shows platelet activation, has been used to show tumor activity in breast, stomach, colon and ovarian cancers.
Recent studies have identified the delta neutrophil index (DNI), which indicates the percentage of immature granulocytes (IG) in peripheral blood due to increased bone marrow activation in inflammatory conditions.It is based on counting granulocyte precursor cells under microscope. With the technological developments,IG count and DNI can be automatically evaluated from complete blood count parameters in automated systems.
In this study, investigators aimed to determine the diagnostic value of preoperative IG number and DNI level before clinical detection of axillary lymph node metastasis, which plays an important role in the prognosis of breast cancer, and to compare these parameters with other routine inflammation markers such as white blood cell count (WBC), MPV, NLR and PLR.
Material - Methods:Patients who were older than eighteen and operated for breast pathology in Kahramanmaras Sutcu Imam University,Department of General Surgery between February 2015 and February 2020 were evaluated retrospectively.Patient data were obtained from patient epicrisis forms and preoperative laboratory and postoperative pathology results recorded in the computer system.Demographic data of the patients,routine blood tests,preoperative imaging methods, preoperative tumor size,presence of axillary lymph node metastasis and distant organ metastasis,presence of pathological axillary lymph node metastasis in the postoperative period were evaluated.
In the preoperative period, patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic(Group NM) and metastasized(Group M) in axillary lymph node sampling.
White blood cell(WBC)count,neutrophil count,lymphocyte count,platelet count,mean platelet volume(MPV),IG count and DNI(IG percentage)were measured using an automated hematological analyzer from blood samples obtained at the preoperative previous month of surgery.Neutrophil to lymhpocyte ratio(NLR) and platelet to lymphocyte ratio(PLR) were manually calculated from the complete blood cell results.
Statistical Evaluation:IBM-Statistical Package for Social Sciences (SPSS) version 20 was used for statistical analysis. In the evaluation between independent groups;normal distribution was checked for the kolmogorov-simirnov test.While student t test or Mann Whitney U test was used in the evaluation of numerical data according to the conformity of the data to normal distribution,chi-square test was used in the evaluation of categorical data.Multivariate analysis was performed with parameters found to be significant in the evaluation of univariate analysis and predictive values of preoperative blood parameters were calculated.ROC analysis was performed to evaluate the effectiveness of WBC, NLR, PLR, DNI, IG number and MPV values,and sensitivity,specificity values and cut-off values were obtained. Numerical values are expressed as median(minimum - maximum values), categorical values as percentage (%).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients without axillary metastases and who did not receive neoadjuvant treatment were examined by dividing them into two groups as pathologically non-metastatic (Group NM) and metastasized (Group M) in axillary lymph node sampling.
| Arm | Type | Receives |
|---|---|---|
| Axillary Lymph Node Metastasis | Other | Procedure: Mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Invasive breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, mixed invasive ductal lobular carcinoma, mucinous carcinoma, medullary carcinoma, micropapillary carcinoma)
- Clinically negative axillarry metastasis(without neoadjuvant chemotherapy/radiotherapy)
- Pathologically positive or negative axillary metastasis
- No missing data.
Key exclusion criteria (6 listed)
- Patients who underwent surgery for benign breast disease (such as fibroadenomas, garnulomatous mastitis, hamartomas)
- Patients with other breast malignancies other than invasive breast carcinoma (ductal carcinoma in situ, fibrosarcomas, neuroendocrine tumors, myofibroblastomas, phyllodes tumors)
- Clinically preoperative positive axillary metastasis
- Preoperative patients with distant organ metastasis
- Patients who received neoadjuvant chemotherapy / radiotherapy in the preoperative period
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 |
|---|---|---|
| MastectomyAlso: Sentinel Lymph Node, Axillary dissection, Complete Blood Count, Delta Neutrophil IndexMastectomy for breast cancer Blood sample for Complete Blood Cell Count and other blood parameters (Delta Neutrophil Index, Immature Granulocyte Count) | Procedure or surgery | Axillary Lymph Node Metastasis |
Primary outcome
Determination of preoperative axillary metastasis in clinically negative patients
Time frame: preoperative period
DNI and IG count calculated automatically in blood samples of the preoperative period of the invasive breast cancer patients
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 2 Feb 2021.
- BackgroundKoc Z, Saglam Z. Determination of the Knowledge and the Practice of Female Patients about breast cancer, Preventive Measures and Breast Self Examination and Effectiveness of Education. Eur J Breast Heal. 2009;5(1):25-33.
- Background: PubMed 28785911Marin Hernandez C, Pinero Madrona A, Gil Vazquez PJ, Galindo Fernandez PJ, Ruiz Merino G, Alonso Romero JL, Parrilla Paricio P. Usefulness of lymphocyte-to-monocyte, neutrophil-to-monocyte and neutrophil-to-lymphocyte ratios as prognostic markers in breast cancer patients treated with neoadjuvant chemotherapy. Clin Transl Oncol. 2018 Apr;20(4):476-483. doi: 10.1007/s12094-017-1732-0. Epub 2017 Aug 7.
- Background: PubMed 31577379DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2.
- Background: PubMed 31684807Peng Y, Chen R, Qu F, Ye Y, Fu Y, Tang Z, Wang Y, Zong B, Yu H, Luo F, Liu S. Low pretreatment lymphocyte/monocyte ratio is associated with the better efficacy of neoadjuvant chemotherapy in breast cancer patients. Cancer Biol Ther. 2020;21(2):189-196. doi: 10.1080/15384047.2019.1680057. Epub 2019 Nov 4.
- Background: PubMed 32369910Miklikova S, Minarik G, Sedlackova T, Plava J, Cihova M, Jurisova S, Kalavska K, Karaba M, Benca J, Smolkova B, Mego M. Inflammation-Based Scores Increase the Prognostic Value of Circulating Tumor Cells in Primary Breast Cancer. Cancers (Basel). 2020 May 1;12(5):1134. doi: 10.3390/cancers12051134.
- Background: PubMed 28532133Elyasinia F, Keramati MR, Ahmadi F, Rezaei S, Ashouri M, Parsaei R, Yaghoubi M, Elyasinia F, Aboutorabi A, Kaviani A. Neutrophil-Lymphocyte Ratio in Different Stages of Breast Cancer. Acta Med Iran. 2017 Apr;55(4):228-232.
- Background: PubMed 17443564Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.
- Background: PubMed 33067685Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
- Background: PubMed 29234189Singh R, Mishra MK, Aggarwal H. Inflammation, Immunity, and Cancer. Mediators Inflamm. 2017;2017:6027305. doi: 10.1155/2017/6027305. Epub 2017 Nov 6. No abstract available.
- Background: PubMed 30830848Ibrahim A, Serkan YF, Tuba A, Erol B, Lutfi P. Can Neutrophil to Lymphocyte Ratio Be a Predictor Tool for The Non-Sentinel Lymph Node Metastasis in Breast Cancer? Chirurgia (Bucur). 2019 Jan-Feb;114(1):83-88. doi: 10.21614/chirurgia.114.1.83.
- Background: PubMed 30426082Taskaynatan H, Alacacioglu A, Kucukzeybek Y, Varol U, Yildiz Y, Salman T, Oflazoglu U, Tarhan MO. Is Monitoring Mean Platelet Volume Necessary in Breast Cancer Patients? Open Med (Wars). 2018 Oct 4;13:450-455. doi: 10.1515/med-2018-0067. eCollection 2018.
- Background: PubMed 31695497Li MM, Yue CX, Fu S, Zhang X, Zhao CJ, Wang RT. Platelet Volume Is Reduced In Metastasing Breast Cancer: Blood Profiles Reveal Significant Shifts. Cancer Manag Res. 2019 Oct 24;11:9067-9072. doi: 10.2147/CMAR.S221976. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mastectomy in people with Breast Cancer and Breast Cancer Invasive, run by Kahramanmaras Sutcu Imam University.
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 4 inclusion and 6 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Determination of preoperative axillary metastasis in clinically negative patients (time frame: preoperative period). 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 NCT04729647, which also lists 15 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 2 Feb 2021.