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临床试验/CTRI/2025/07/089974
CTRI/2025/07/089974尚未招募不适用

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.

Datta Meghe Institute of Higher Education and Research (DMIHER)1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
This study investigates the signifance of Neutrophil- Lymphocyte ratio as a predictive tumour behaviour marker in correlation to established histopathological and immunohistochemistry parameters.

研究概览

简要总结

**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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • All female patients undergoing mastectomy for breast cancer during the study period were included.
  • All female patients diagnosed with breast carcinoma on histopathological examination.

排除标准

  • All the patients whose treatment had already started before the pre treatment NLR was determined.
  • All male breast cancer patients were excluded from the study.
  • All patients diagnosed with lesions other than carcinoma like benign breast lesions, mesenchymal tumors were excluded.
  • All patients who have undergone incisional biopsy, trucut biopsy and diagnosed with breast carcinoma.

结局指标

主要结局

This study investigates the signifance of Neutrophil- Lymphocyte ratio as a predictive tumour behaviour marker in correlation to established histopathological and immunohistochemistry parameters.

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research (DMIHER)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prita Hejib

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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