Clinical trial · Observational
Tumor Budding and T1 Substaging in Urothelial Bladder Cancer
Assessment of Tumor Budding and T1 Substaging as Histopathological Predictors of Outcome in Urothelial Bladder Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding). Researchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024. The tissue samples will be analyzed in two main ways: * Early-stage tumors (pT1 cases): Researchers will carefully measure the exact depth the tumor has invaded the bladder lining using anatomical and micrometric sub-classification systems. * More advanced tumors (pT2 cases): Researchers will examine the invasive edge of the tumors under a microscope to count "tumor buds" (single cells or small clusters of cells). By comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Muscle-Invasive Bladder Cancer (MIBC) | — | UNRESOLVED | — |
| Non-Muscle-Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
| Urothelial Bladder Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- pT1 Urothelial Carcinoma Cases
- description
- All confirmed pT1 cases will undergo rigorous histopathological substaging. An anatomical substaging (T1a/b/c) will be performed by identifying the level of invasion relative to the muscularis mucosae. Additionally, micrometric assessment will be carried out using a 0.1 mm threshold and the Rete Oncologica Lombarda (ROL) system.
- label
- pT2 Urothelial Carcinoma Cases
- description
- These cases will be evaluated for Tumor Budding. The "Hotspot" method will be used to count buds in one high power field at the invasive front. Cases will be graded as Low Budding (BD1): 0-4 buds, Intermediate Budding (BD2): 5-9 buds, and High Budding (BD3): ≥ 10 buds.
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).
- description
- Overall survival is defined as the length of time from the date of the transurethral resection (TUR) to the date of death from any cause. This outcome will be correlated with the assessed histopathological parameters (T1 substaging and Tumor Budding scores) to evaluate their prognostic significance in urothelial bladder carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma. * Patients with full clinical data and complete medical reports. Exclusion Criteria: * Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma). * Patients who received neoadjuvant chemotherapy or radiotherapy. * Cases with missing or inaccessible clinical follow-up data. * History of prior or concurrent malignancy.
References
Publications (0)
Data not yet available