Tumor Budding and T1 Substaging in Urothelial Bladder Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.

Patients with full clinical data and complete medical reports.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: pT1 Urothelial Carcinoma Cases
Group B: pT2 Urothelial Carcinoma Cases

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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