| 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
|
|
|
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
|
|
|
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. |