Tumor Budding and T1 Substaging in Urothelial Bladder Cancer

NCT07529639 | Not Yet Recruiting

• 1 other identifier: T1 & Budding in Bladder Cancer
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Urothelial Bladder Carcinoma; Bladder Carcinoma; Non-Muscle-Invasive Bladder Cancer (NMIBC); Muscle-Invasive Bladder Cancer (MIBC)

Keywords

Tumor Budding; T1 Substaging; Histopathology; Disease Progression; Survival Outcomes; Transurethral Resection (TUR); Epithelial-Mesenchymal Transition (EMT); Invasion Depth

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).

Study Arms (2)

pT1 Urothelial Carcinoma Cases

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.

pT2 Urothelial Carcinoma Cases

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with urothelial bladder carcinoma who underwent transurethral resection (TUR) at the South Egypt Cancer Institute (SECI), Assiut University, between the years 2018 and 2024. The study utilizes retrospectively collected, archived paraffin-embedded tissue blocks along with corresponding clinical, pathological, and survival data retrieved from medical records and electronic pathology reports.

You may qualify if:

• Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.
• Patients with full clinical data and complete medical reports.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Pathology at South Egypt Cancer Institute, Assiut University

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04