The Relationship Between the Density of Cancer-Associated Fibroblasts in the Peritumoral Stroma and Clinicopathological Data in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Detection of Cancer-Associated Fibroblasts via Immunohistochemical Analysis
研究概览
简要总结
Research Question:
Is there a relationship between the clinical prognosis and pathological data of breast cancer patients and the density of cancer-associated fibroblasts in the peritumoral stroma?
Objectives of the Study:
- Detection of cancer-associated fibroblasts in the tumor microenvironment across different breast cancer subtypes.
- Examination of the correlation between the clinical prognosis and pathological data of patients with different breast cancer subtypes and cancer-associated fibroblast subtypes.
The goal of this study based on the correlation obtained, the aim is to propose cancer-associated fibroblasts as a more effective marker for breast cancer classification and prognosis.
详细描述
During the routine marking before neoadjuvant chemotherapy of breast cancer patients with triple-negative, HER2-positive, or Luminal B molecular subtypes, the correlation between the density of cancer-associated fibroblasts in the samples taken from the center of the tumor and the peritumoral stroma of the same mass with the patient's clinical prognosis and pathological data will be examined.
Approach and Methods:
Collection of Tissue Samples via Core Needle Biopsy from Breast Cancer Patients (Luminal B, HER2 Group, and Triple-Negative Group):
Breast masses will be examined supine using an ultrasound machine with a 14 MHz linear transducer. The tumor and peritumoral parenchyma will be evaluated using a 1.5 T MRI machine with a 16-channel breast coil, in the prone position, under dynamic contrast-enhanced and diffusion-weighted imaging guidance. Under sonographic guidance and local anesthesia, one tissue sample will be taken from the center of the mass using a 14G/10 cm core needle immediately before marking for neoadjuvant chemotherapy. One tissue sample will be taken from the peritumoral stroma where diffusion restriction is shown in diffusion-weighted MRI from patients diagnosed with Luminal B, HER2, or triple-negative malignancy.
Identification of Cancer-Associated Fibroblasts via Immunohistochemical Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with histopathologically confirmed Luminal B, HER2-positive, or triple-negative breast cancer subtypes.
- •Patients who have not previously received any neoadjuvant chemoradiotherapy.
- •Patients over 18 years of age.
- •Adequate cellularity in biopsies obtained via core needle biopsy.
排除标准
- •Patients diagnosed with histopathologically confirmed Luminal A breast cancer subtype.
- •Patients who have previously received any neoadjuvant chemoradiotherapy.
- •Patients under 18 years of age.
- •Inadequate cellularity in biopsies obtained via core needle biopsy.
研究组 & 干预措施
1- Subtyping of Breast Cancer Patients.
Biopsy collection from patients who were diagnosed with breast cancer, subtyping of biopsy materials, and identification of patients with Luminal A, Luminal B, HER2 positive group, and triple-negative types.
干预措施: Immunohistochemistry Analysis (Other)
5- Surgery Phase
Surgery after neoadjuvant chemotherapy
干预措施: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure)
2- Identification of patients to be included in the study.
Identification of patients diagnosed with breast cancer who meet the study's eligibility criteria.
3- Second Biopsy
Taking biopsies from the center of the tumor and the peritumoral stroma of the same mass during marking of the mass before neoadjuvant chemotherapy
干预措施: Second Biopsy (Procedure)
4- Detection of cancer-associated fibroblasts
Analysis of cancer-associated fibroblasts using immunohistochemical methods on materials taken from the periphery and center of patients' tumors during the second biopsy.
6- Statistically Analyze
The investigators compare cancer-associated fibroblast densities by analyzing monitored patients' clinical and pathological data and statistically analyze and interpret the results.
结局指标
主要结局
Detection of Cancer-Associated Fibroblasts via Immunohistochemical Analysis
时间窗: Within 4 weeks after immunohistochemical staining.
The detection of cancer-associated fibroblasts will be conducted separately using each immunohistochemical stain, and after the density(percentage) and intensity(will be scored 1 to 4) are assessed, the H-score(percentage X intensity score) will be determined by an expert pathologist, followed by grouping.
次要结局
- Collecting Patient Information From The Hospital System(Within 1 year after surgery)
研究者
Dogukan Akkus
Principal Investigator
Haydarpasa Numune Training and Research Hospital