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临床试验/NCT07003776
NCT07003776尚未招募不适用

Evaluation of Tumor Budding In Colorectal Adenocarcinoma

Sohag University0 个研究点目标入组 50 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Evaluation of Tumor Budding in Colorectal Adenocarcinoma

研究概览

简要总结

Colorectal cancer (CRC) is among the most prevalent cancers globally, with approximately one to two million new cases diagnosed each year. This makes CRC the third most common cancer and the fourth leading cause of cancer-related deaths, with 700,000 deaths per year, exceeded only by lung, liver and stomach cancers. CRC accounts for about 10% of all cancer diagnoses worldwide (Sung et al., 2021; Masetti et al., 2022) .

CRC affects different races and ethnicities at various age groups in distinct ways. Among patients younger than 50 years old, the proportion of CRC is nearly double for Black individuals (16%) compared to White individuals (9%) and Hispanic individuals (6%). In Egypt, CRC ranked the seventh among cancers, following lung, breast, prostate, liver, and bladder cancers (Mounir et al., 2022).

Tumor budding (TB) is characterized by the presence of individual tumor cells or small clusters of up to four cells at the invasive margin of a tumor. This histological feature, which indicates the separation of malignant cells from the main tumor mass, has intrigued pathologists since it was first identified in the 1950s (Giordano et al., 2024).

Evaluating TB is crucial for improving prognostic accuracy and informing treatment decisions. Tumors with high-grade TB exhibit a significantly lower 5-year Disease-Free Survival (DFS) rate compared to those with low-grade TB. High-grade TB is regarded as a negative prognostic factor and is associated with an increased risk of recurrence (Kyong Shin et al., 2023).

TB can be observed in conventional slides when prominent, but careful observation is necessary. A more thorough assessment of TB is more easily achieved if the neoplastic epithelium is highlighted using pan-cytokeratin immunostains (Mishra et al., 2022).

Pan-keratin (Pan-CK) antibodies are proteins derived from cytoskeletal intermediate filaments. These antibodies are a mixture designed to detect multiple low and high molecular weight keratins. Their primary purpose is to allow for the immunohistochemical identification of all epithelial cell types, regardless of their tissue of origin, using a single diagnostic tool.

In surgical pathology, Pan-CK antibodies are commonly used to confirm the epithelial origin of both neoplastic (tumorous) and non-neoplastic tissues, as well as to identify small metastases in lymph nodes. However, there are limitations to the assumption that Pan-CK antibodies will stain all epithelial tumors and that non-epithelial tissues will be "keratin negative." It has been reported that a diverse range of epithelial tumors can be Pan-CK negative, challenging the notion that these antibodies are universally applicable (Wick et al., 1986; Badzio, 2019).

Pan-CK can help diagnose disease like breast cancer, lung cancer, prostate cancer, and colorectal cancer. It is often used in conjunction with other antibodies for these specific cancers (Chu and Weiss, 2002).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.

排除标准

  • Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.

结局指标

主要结局

Evaluation of Tumor Budding in Colorectal Adenocarcinoma

时间窗: 6 months

Histological assessment and immunohistochemical highlighting of tumor Budding by Pan-CK.

次要结局

  • Correlation of Tumor Budding with clinicopathological parameters(6 months)

研究者

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

Shaza Mostafa Galal Mostafa

demonstrator at pathology department

Sohag University

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