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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

13 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

30

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Abbasia
      • Cairo, Abbasia, Egipto
        • Faculty of medicine, Ain Shams university

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

  • 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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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,

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2022

Finalización primaria (Actual)

1 de junio de 2024

Finalización del estudio (Actual)

1 de junio de 2024

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de junio de 2026

Última verificación

1 de enero de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FMASU MS 332/2022
  • URO 37 12 28 (Otro identificador: Theodor bilharz research institution)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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