FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/089974 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Neutrophil- Lymphocyte Ratio as a predictive tumor behavior marker in breast cancer patients.  
Scientific Title of Study   To Study Utility of Neutrophil Lymphocyte Ratio as a Predictive Tumor Behavior Marker in Comparison to the Established Histopathological and Immuno-histochemistry Parameters in Breast Cancer Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prita Hejib  
Designation  Junior Resident  
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.

Wardha
MAHARASHTRA
442107
India 
Phone  9561731126  
Fax    
Email  pritahejib@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunita Vagha  
Designation  Professor  
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.

Wardha
MAHARASHTRA
442107
India 
Phone  9860244638  
Fax    
Email  sunitavagha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prita Hejib  
Designation  Junior Resident  
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.

Wardha
MAHARASHTRA
442107
India 
Phone  9561731126  
Fax    
Email  pritahejib@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi Meghe, Wardha, Maharashtra- 442107 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi Meghe, Wardha, Maharashtra- 442107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prita Hejib  Acharya Vinoba Bhave Rural Hospital   Department of General Surgery and Surgical Oncology, AVBRH and Siddharth Gupta Memorial Hospital, Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA 
9561731126

pritahejib@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (Deemed to be University)Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. All female patients undergoing mastectomy for breast cancer during the study period were included.
2. All female patients diagnosed with breast carcinoma on histopathological examination.
3. All females with breast carcinoma with no history of previous treatment for the same 
 
ExclusionCriteria 
Details  1. All the patients whose treatment had already started before the pre treatment NLR was determined.
2. All male breast cancer patients were excluded from the study.
3. All patients diagnosed with lesions other than carcinoma like benign breast lesions, mesenchymal tumors were excluded.
4. All patients who have undergone incisional biopsy, trucut biopsy and diagnosed with breast carcinoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study investigates the signifance of Neutrophil- Lymphocyte ratio as a predictive tumour behaviour marker in correlation to established histopathological and immunohistochemistry parameters.   2 years  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   BACKGROUND- 

Breast cancer is the most common type of cancer affecting women in reproductive age. It is one of the leading malignant tumors that endanger women’s health worldwide. As per GLOBOCAN 2020, the incidence of breast cancer accounts for about 24.5% of all cancers in females worldwide. The incidence of breast cancer is around 26.6% in India in females with a mortality rate of 22% as of 2022. Breast cancer is the most frequently diagnosed and the leading cause of cancer death among females worldwide. In 2020, there were 2.3 million women diagnosed with breast cancer and 685,000 deaths globally. As of the end of 2020, there were 7.8 million women alive who were diagnosed with breast cancer in the past 5 years, making it the world’s most prevalent cancer. Breast cancer prognosis can be determined by various factors such as age, risk factors, family history, histological type, molecular subtype, stage of cancer. However inflammation plays a very crucial role in the development, progression, metastasis and relapse of tumour. Systemic inflammatory response is associated with tumour progression and affects the human host immune response to malignant tumours. Inflammatory cells can cause modification of tumour and its microenvironment by direct interaction with the tumour cells and hence can be both tumour promoting as well as tumour antagonising. The predominant cells are the neutrophils which release growth factors and proteases which help in invasion, progression, angiogenesis and metastasis. Biomarkers such as neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio, mean platelet volume, platelet-lymphocyte ratio, lymphocyte-monocyte ratio have been proposed as potential predictive factors for various types of cancers. Neutrophils promote tumour spread whereas T lymphocytes are protective against cancer. The neutrophil-to-lymphocyte ratio is increased in all types of cancers and has been studied as a predictive marker in various other types of malignancies. It is higher in patients with more advanced cancers and correlates with poor survival in many cancers. NL Ratio reflects the myeloid and lymphocytic lineages in peripheral smear and is a sensitive marker of altered myelopoiesis arising in cancer. NL ratio has also been studied in many other cancers like renal carcinoma, colon cancer, but very few studies have been done on breast cancers. The NL ratio is obtained by dividing the Absolute Neutrophil Count (ANC) as the numerator and Absolute Lymphocyte Count (ALC) as the denominator, which is simply obtained from a Complete Blood Count (CBC).

METHODOLOGY-  An observational, cross sectional, retrospective type of study will be conducted over a span of two years (November 2023 to November 2025) in the Central Clinical Laboratory, Histopathology and Immuno-histochemistry sections of Pathology Department at Jawaharlal Nehru Medical College, Sawangi (Meghe) in coordination with Department of General Surgery and Surgical Oncology at Acharya Vinoba Bhave Rural Hospital, Shalinitai Meghe Superspeciality and Siddharth Gupta Memorial Hospital. Informed consent will be taken from the patients included in this study and approval is given by the Institutional Ethics Committee (IEC) at DMIHER. Study population will include all female patients undergoing mastectomy surgery for breast lump. Statistical analysis will be carried out by using ‘Chi-Square Test’ with Statistical significance set at p value < 0.05.

CONCLUSION-   A conclusion will be drawn from the obtained Neutrophil- Lymphocyte Ratio and its correlation to histopathological parameters (TNM and AJCC staging) and immunohistochemistry parameters (ER, PR, Her2Neu, Ki67) to determine the prognosis of patients with breast carcinoma. 

 
Close