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Predictive Value of E-cadherin, β-catenin and SOX4 in Recurrence and/or Progression of Non-muscle Invasive Urinary Bladder Transitional Cell Carcinoma. A Retrospective Study

2026年6月13日 更新者:Ain Shams University

Bladder cancer is common tumor in which recurrence and/or progression in patients undergoing TUR has been reported to range between 30% and 80% in patients with NMIBC TCC.

With evidence of E-cadherin, β-catenin and SOX4 playing a role in the development of tumors, it manifests as invasion and metastasis.

In this study, we hope to develop the correlation regarding the alternation in the expression of E-cadherin, β-catenin and Sox4 in determining the recurrence, progression and up staging and their prognostic value in NMIBC.

研究概览

地位

完全的

详细说明

Bladder cancer (BC) is one of the most common genitourinary malignancies worldwide. [1]

The incidence of BC increases with age, with a high incidence among those 50-70 years old. The incidence of BC in males is three- to four-times higher than that in females [2]. The etiology and pathogenesis of BC are complex, with both internal genetic factors and external environmental factors. Smoking and occupational exposure to aromatic amine chemicals (such as aniline, 2-aminobiphenyl, 2-naphthalene, 1-naphthalamines etc.) are the two major risk factors for BC [3].

At present, some studies suggest that the abnormal function of intercellular adhesion molecules is highly correlated with the invasion of surrounding tissues and distant organ metastasis of BC [4].

BC is typically grouped into two main pathological classes non-muscular invasive bladder cancer (NMIBC) which is further sub classified according to histological grade (low or high), and muscular invasive bladder cancer (MIBC) according to the European Association of Urology (EAU) guidelines. BC can also be divided into several types-transitional cell carcinoma (TCC), squamous epithelial carcinoma, and adenocarcinoma-among which over 90% are TCC [5].

While histological and pathological grading and staging systems exist for some time, recent advances in genomic sequencing have lent insight into molecular characterizations that stratify patients into various subtypes based on genetic markers, such as amplifications, mutations and deletions [6].

The current standard treatment of patients with non-muscle-invasive bladder cancer (NMIBC) is complete removal of the visible tumor burden by transurethral resection (TUR), and the prognosis of such patients is generally favorable, achieving 5-year survival rates greater than 80% [7].

However, the high probability of intravesical recurrence in patients undergoing TUR has been reported to range between 30% and 80% in patients with NMIBC [7-8]. Intensive efforts, therefore, have been made to identify factors precisely predicting the clinical course of NMIBC following TUR, which are of great utility in planning both postoperative adjuvant therapy and follow-up schedule in an individual patient.

Of patients with BC 50% to 55% present with Ta tumors, for which recurrence is the main clinical issue, occurring in up to 80% [9-10].

However, for the 20% to 25% of patients presenting with T1 tumors, progression is the main clinical concern, occurring in up to 45% [9-10]. Progression to or presentation with muscle invasive disease (stage T2-4) represents the critical step in the disease course of bladder cancer, Necessitating more radical and aggressive therapies, including surgery, chemotherapy or radiotherapy, and carrying a 5-year survival rate of only 27% to 50% [10].

These aggressive therapies represent relatively crude approaches with significant morbidity and mortality [11].

Cadherins are the main mediators of cell-cell adhesion in epithelial tissues; E-cadherin is an important transmembrane glycoprotein of epithelial cell adhesion. It is also an inhibitor of tumor invasion and metastasis. It plays an important role in maintaining cell morphology, cell movement, and adhesion function [12].

E-cadherin needs β-catenin to mediate and participate in its physiological function. β-catenin is an E-cadherin-related protein. The intracellular domain of E-cadherin is connected with β-catenin to form a β-catenin/E-cadherin complex, which is transported to the cell membrane through the cytoplasm and inserted into the cell membrane to maintain the polarity and stability of epithelial cells [13].

In the process of tumorigenesis, the abnormality of β-catenin affects the stability of the β-catenin/E-cadherin complex, which leads to a decrease in cell junction density and the loss of cell contact inhibition function. In the development of tumors, it manifests as invasion and metastasis [13-14].

Furthermore, the abnormal expression of Cadherins (cadherin switching) has been shown to promote a more invasive and malignant phenotype of cancer, and possibly even acts as the principal mediator of invasion and metastasis in BC [15].

SOX (SRY-related HMG-box) family of transcription factors involved In organogenesis of various organs. One of the candidate is located at the chromosome 6p22 locus is Sox4 [16],

SOX4 gene expression is upregulated in many cancer types, and it's increase activity contributes to cellular transformation, cell survival, and metastasis [17].

SOX family of proteins are found in all metazoans, and high expression of SOX4 has been used to recognize the presence of CSCs. This approach has been applied in some studies of TCC [18].

The cancer stem cells (CSCs) hypothesis is based on the observation of many cancers, including bladder cancer, are driven by a subpopulation of tumor-initiating cells (popularly known as CSCs) and promote tumor growth. In addition, CSCs are resistant to chemotherapy and radiation treatments, which potentially explains the limitations of curing human malignancies [19].

Down-regulation of SOX4 led to mesenchymal-to-epithelial transition (MET) and inhibition of cell migration. Of note, knockdown of SOX4 reduced sphere formation, aldehyde-dehydrogenase-high (ALDH) cell population and potential of tumor formation. Furthermore, immunohistochemistry (IHC) analysis of human bladder tumor tissue microarrays (TMAs) indicated that high SOX4 expression correlated with advanced tumor stages and poorer survival of urinary bladder cancer patients. Providing the first evidence, that SOX4 may act as an oncogene [20].

In this study, we hope to develop the correlation regarding the alternation in the expression of E-cadherin, β-catenin and Sox4 in determining the recurrence, progression and up staging and their prognostic value in NMIBC.

研究类型

观察性的

注册 (实际的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Abbasia
      • Cairo、Abbasia、埃及
        • Faculty of medicine, Ain Shams university

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

  • Inclusion Criteria:

    1. The patients were treated with transurethral resection of bladder tumor finally diagnosed with NMIBC TCC by pathological examination.
    2. The controls were normal bladder tissues. Or patients diagnosed with cystitis or dysplasia on pathological examination
  • Exclusion Criteria:

    1. Age at the time of cancer diagnosis > 70 years
    2. Patients diagnosed with MIBC
    3. Patients with concomitant upper urinary tracts tumors
    4. Patients with concomitant prostatic tumors
    5. Patients diagnosed with TCC T1 who did not received full induction, or maintenance doses BCG
    6. Patients showed BCG toxicity signs
    7. Patients diagnosed with TCC T1 who did not underwent 2nd look TURBT
    8. Patients with known genetic/congenital disorder that may interfere with/or increase risk of BC;
    9. Patients with history of chemotherapy or pelvic radiations for other tumor treatment than BC

描述

Inclusion criteria:

1. The patients were treated with transurethral resection of bladder tumor finally diagnosed with NMIBC TCC by pathological examination.

2. The controls were normal bladder tissues. Or patients diagnosed with cystitis or dysplasia on pathological examination

- Exclusion Criteria:

  1. Age at the time of cancer diagnosis > 70 years
  2. Patients diagnosed with MIBC
  3. Patients with concomitant upper urinary tracts tumors
  4. Patients with concomitant prostatic tumors
  5. Patients diagnosed with TCC T1 who did not received full induction, or maintenance doses BCG
  6. Patients showed BCG toxicity signs
  7. Patients diagnosed with TCC T1 who did not underwent 2nd look TURBT
  8. Patients with known genetic/congenital disorder that may interfere with/or increase risk of BC;

    • Bladder exstrophy.
    • Rb1: An altered form of Rb1, retinoblastoma gene, is associated with cancer of the eye in infants, and may increase your bladder cancer risks.
    • Cowden disease: This syndrome, linked to an abnormal form of the gene PTEN, may trigger breast cancer and thyroid cancer, and increases the risk of bladder cancer.
    • Lynch syndrome: This genetic condition, also known as hereditary non-polyposis colorectal cancer, is usually tied to colon and endometrial cancer. However, this syndrome may also increase the risk of bladder cancer and cancer of the ureter.
  9. Patients with history of chemotherapy or pelvic radiations for other tumor treatment than BC

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
30 patients who treated with transurethral resection of bladder tumor finally diagnosed with NMIBC
  • Inclusion Criteria:

    1. The patients were treated with transurethral resection of bladder tumor finally diagnosed with NMIBC TCC by pathological examination.
    2. The controls were normal bladder tissues. Or patients diagnosed with cystitis or dysplasia on pathological examination
  • Exclusion Criteria:

    1. Age at the time of cancer diagnosis > 70 years
    2. Patients diagnosed with MIBC
    3. Patients with concomitant upper urinary tracts tumors
    4. Patients with concomitant prostatic tumors
    5. Patients diagnosed with TCC T1 who did not received full induction, or maintenance doses BCG
    6. Patients showed BCG toxicity signs
    7. Patients diagnosed with TCC T1 who did not underwent 2nd look TURBT
    8. Patients with known genetic/congenital disorder that may interfere with/or increase risk of BC;

      • Bladder exstrophy.
      • Rb1: An altered form of Rb1, retinoblastoma gene, is associated with cancer of the eye in infants,

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
This study aims to develop correlation regarding the alternation in the expression of E-cadherin, β-catenin and SOX4 in determining the recurrence and/or progression and their prognostic value in NMIBC TCC.
大体时间:2 years
This study aims to develop correlation regarding the alternation in the expression of E-cadherin, β-catenin and SOX4 in determining the recurrence and/or progression and their prognostic value in NMIBC TCC.
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月1日

初级完成 (实际的)

2024年6月1日

研究完成 (实际的)

2024年6月1日

研究注册日期

首次提交

2026年6月13日

首先提交符合 QC 标准的

2026年6月13日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月13日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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