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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. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

  • 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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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,

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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

Mitarbeiter und Ermittler

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Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2022

Primärer Abschluss (Tatsächlich)

1. Juni 2024

Studienabschluss (Tatsächlich)

1. Juni 2024

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2026

Zuerst gepostet (Tatsächlich)

18. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. Januar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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