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临床试验/NCT05250336
NCT05250336Unknown不适用

Prognostic and Predictive Value of Tumor-Infiltrating Lymphocytes and Programmed Cell Death - Ligand 1 in Breast Cancer

Sanjay Gandhi Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Correlation of TILs and PDL-1 in various molecular sub-types

研究概览

简要总结

The morphological evaluation of Tumor-infiltrating Lymphocytes (TILs) in breast cancer is gaining momentum as evidence strengthens for the clinical relevance of this immunological biomarker. In breast cancer (BC) lesions, TILs are seen in intratumoral and stromal areas. TILs are predictive of response to treatment and this association appears to be strongest in Triple-negative (TNBC) and Her 2 (Human epidermal growth factor receptor) positive breast cancer subtypes. Contrastingly, the association in Estrogen Receptor (ER) positive, HER 2 negative tumors have not been established.

Programmed cell death 1 (PD-1), are receptors expressed on the surface of T, B, and Natural killer cells and in some tumor cells. These attenuate the cellular immune response by inducing T-cell apoptosis. Programmed Cell Death Ligand 1 (PD-L1) overexpression is reported to be associated with large tumor size, lymph node metastasis, and ER-negativity. Importantly, PD-L1 is expressed more frequently in TNBC patients. High PD-L1 expression may be a prognostic indicator for reduced overall survival6. This information may be helpful to screen candidates for anti-PD-1/PD-L1 therapy, especially patients with TNBC The aim of this study is to characterize the cohort of patients with breast cancer based on a semiquantitative assessment of TILs and to correlate the concentration of TILs and PD-L1 in various intrinsic subtypes (based on Immunohistochemistry) with the overall outcome. Also to correlate the TILs and PD-L1 expression with tumor response to Neoadjuvant Chemotherapy (NACT) and to stratify the predictive value of this biomarker in TNBC.

详细描述

This is a retrospective and prospective study in patients with Primary Breast cancer at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI). This is a time-bound study, where we include all patients treated between January 2016 and December 2021 who meet the inclusion criteria. We screened out approximately 2000 patients treated over this period, of which about 1000 had met inclusion criteria.

The electronic and physical records of all breast cancer patients maintained in Hospital Information System and Department of Breast and Endocrine Surgery at SGPGI have been screened to identify all appropriate cases and their clinical data were reviewed.

The cohort of patients who met the inclusion criteria was identified from the screened data.

The paraffin blocks of pre-therapeutic core biopsies/ surgical specimens of the study subjects were retrieved and the same from prospective study subjects were included.

Existing data on Immunohistochemistry (IHC) for ER (Estrogen Receptor), PR (Progesterone Receptor), Her 2 neu (Human epidermal growth factor receptor) was tabulated to identify TNBC cohort.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary Breast cancer
  • Completed scheduled treatment at SGPGI
  • Adequate quality histopathology material available in Department of Pathology archives
  • With minimum 6 months follow up

排除标准

  • Insufficient data
  • Incomplete treatment
  • Insufficient follow up information
  • Insufficient histological material for review

结局指标

主要结局

Correlation of TILs and PDL-1 in various molecular sub-types

时间窗: Range of 6 months - 6 years follow up

To Correlate the concentration of TILs and PD-L1 in various intrinsic subtypes (based on Immunohistochemistry) with the overall outcome

PD-L1 expression and Tumor response to treatment

时间窗: Time frame range of 6 months to 6 years follow up

To Correlate PD-L1 expression with response to Neoadjuvant Chemotherapy in patients with TNBC

PDL-1 expression in patients with Triple Negative Breast Cancer (TNBC)

时间窗: a follow up period of 6 months to 6 years

To Correlate PDL-1 expression with outcomes in patients with TNBC

TILs and Tumor response to treatment

时间窗: a follow-up time frame Range from 6 months to 6 years

To Correlate the TILs with tumor response to Neoadjuvant Chemotherapy and to stratify the predictive value of this biomarker

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gaurav Agarwal

Professor of Endocrine and Breast Surgery

Sanjay Gandhi Postgraduate Institute of Medical Sciences

研究点 (1)

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