NCT07657299

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

β-catenin, E-cadherin, NMIBC, progression, recurrence, SOX4

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

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,

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* 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

You may qualify if:

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

You may not qualify if:

  • Age at the time of cancer diagnosis \> 70 years
  • Patients diagnosed with MIBC
  • Patients with concomitant upper urinary tracts tumors
  • Patients with concomitant prostatic tumors
  • Patients diagnosed with TCC T1 who did not received full induction, or maintenance doses BCG
  • Patients showed BCG toxicity signs
  • Patients diagnosed with TCC T1 who did not underwent 2nd look TURBT
  • 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.
  • Patients with history of chemotherapy or pelvic radiations for other tumor treatment than BC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Ain Shams University

Cairo, Abbasia, Egypt

Location

Related Publications (20)

  • Du Y, Spence SE, Jenkins NA, Copeland NG. Cooperating cancer-gene identification through oncogenic-retrovirus-induced insertional mutagenesis. Blood. 2005 Oct 1;106(7):2498-505. doi: 10.1182/blood-2004-12-4840. Epub 2005 Jun 16.

    PMID: 15961513BACKGROUND
  • Chan KS, Espinosa I, Chao M, Wong D, Ailles L, Diehn M, Gill H, Presti J Jr, Chang HY, van de Rijn M, Shortliffe L, Weissman IL. Identification, molecular characterization, clinical prognosis, and therapeutic targeting of human bladder tumor-initiating cells. Proc Natl Acad Sci U S A. 2009 Aug 18;106(33):14016-21. doi: 10.1073/pnas.0906549106. Epub 2009 Aug 4.

    PMID: 19666525BACKGROUND
  • Ojha R, Singh SK, Bhattacharyya S, Dhanda RS, Rakha A, Mandal AK, Jha V. Inhibition of grade dependent autophagy in urothelial carcinoma increases cell death under nutritional limiting condition and potentiates the cytotoxicity of chemotherapeutic agent. J Urol. 2014 Jun;191(6):1889-98. doi: 10.1016/j.juro.2014.01.006. Epub 2014 Jan 15.

    PMID: 24440234BACKGROUND
  • Tiwari N, Tiwari VK, Waldmeier L, Balwierz PJ, Arnold P, Pachkov M, Meyer-Schaller N, Schubeler D, van Nimwegen E, Christofori G. Sox4 is a master regulator of epithelial-mesenchymal transition by controlling Ezh2 expression and epigenetic reprogramming. Cancer Cell. 2013 Jun 10;23(6):768-83. doi: 10.1016/j.ccr.2013.04.020.

    PMID: 23764001BACKGROUND
  • Lioubinski O, Muller M, Wegner M, Sander M. Expression of Sox transcription factors in the developing mouse pancreas. Dev Dyn. 2003 Jul;227(3):402-8. doi: 10.1002/dvdy.10311.

    PMID: 12815626BACKGROUND
  • Yilmaz M, Christofori G. EMT, the cytoskeleton, and cancer cell invasion. Cancer Metastasis Rev. 2009 Jun;28(1-2):15-33. doi: 10.1007/s10555-008-9169-0.

    PMID: 19169796BACKGROUND
  • Kashibuchi K, Tomita K, Schalken JA, Kume H, Takeuchi T, Kitamura T. The prognostic value of E-cadherin, alpha-, beta- and gamma-catenin in bladder cancer patients who underwent radical cystectomy. Int J Urol. 2007 Sep;14(9):789-94. doi: 10.1111/j.1442-2042.2007.01830.x.

    PMID: 17760743BACKGROUND
  • Umbas R, Isaacs WB, Bringuier PP, Xue Y, Debruyne FM, Schalken JA. Relation between aberrant alpha-catenin expression and loss of E-cadherin function in prostate cancer. Int J Cancer. 1997 Aug 22;74(4):374-7. doi: 10.1002/(sici)1097-0215(19970822)74:43.0.co;2-s.

    PMID: 9291424BACKGROUND
  • Bringuier PP, Umbas R, Schaafsma HE, Karthaus HF, Debruyne FM, Schalken JA. Decreased E-cadherin immunoreactivity correlates with poor survival in patients with bladder tumors. Cancer Res. 1993 Jul 15;53(14):3241-5.

    PMID: 8324734BACKGROUND
  • Lorusso V, Silvestris N. Systemic chemotherapy for patients with advanced and metastatic bladder cancer: current status and future directions. Ann Oncol. 2005 May;16 Suppl 4:iv85-89. doi: 10.1093/annonc/mdi914. No abstract available.

    PMID: 15923437BACKGROUND
  • Wallace DM, Bryan RT, Dunn JA, Begum G, Bathers S; West Midlands Urological Research Group. Delay and survival in bladder cancer. BJU Int. 2002 Jun;89(9):868-78. doi: 10.1046/j.1464-410x.2002.02776.x.

    PMID: 12010230BACKGROUND
  • van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.

    PMID: 19576682BACKGROUND
  • Millan-Rodriguez F, Chechile-Toniolo G, Salvador-Bayarri J, Palou J, Vicente-Rodriguez J. Multivariate analysis of the prognostic factors of primary superficial bladder cancer. J Urol. 2000 Jan;163(1):73-8. doi: 10.1016/s0022-5347(05)67975-x.

    PMID: 10604317BACKGROUND
  • Oosterlinck W. The management of superficial bladder cancer. BJU Int. 2001 Jan;87(2):135-40. doi: 10.1046/j.1464-410x.2001.00948.x. No abstract available.

    PMID: 11167630BACKGROUND
  • Aine M, Eriksson P, Liedberg F, Hoglund M, Sjodahl G. On Molecular Classification of Bladder Cancer: Out of One, Many. Eur Urol. 2015 Dec;68(6):921-3. doi: 10.1016/j.eururo.2015.07.021. Epub 2015 Jul 26.

    PMID: 26215606BACKGROUND
  • EAU Guidelines. Edn. presented at the EAU Annual Congress Copenhagen 2018. ISBN 978-94-92671-01-1.

    BACKGROUND
  • Shimazui T, Schalken JA, Giroldi LA, Jansen CF, Akaza H, Koiso K, Debruyne FM, Bringuier PP. Prognostic value of cadherin-associated molecules (alpha-, beta-, and gamma-catenins and p120cas) in bladder tumors. Cancer Res. 1996 Sep 15;56(18):4154-8.

    PMID: 8797585BACKGROUND
  • Kiriluk KJ, Prasad SM, Patel AR, Steinberg GD, Smith ND. Bladder cancer risk from occupational and environmental exposures. Urol Oncol. 2012 Mar-Apr;30(2):199-211. doi: 10.1016/j.urolonc.2011.10.010.

    PMID: 22385990BACKGROUND
  • Ploeg M, Aben KK, Kiemeney LA. The present and future burden of urinary bladder cancer in the world. World J Urol. 2009 Jun;27(3):289-93. doi: 10.1007/s00345-009-0383-3. Epub 2009 Feb 15.

    PMID: 19219610BACKGROUND
  • Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1998. CA Cancer J Clin. 1998 Jan-Feb;48(1):6-29. doi: 10.3322/canjclin.48.1.6.

    PMID: 9449931BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cystoscopic Bladder mass biopsies

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsDisease ProgressionRecurrence

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start

April 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 18, 2026

Record last verified: 2026-01

Locations