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NCT07529639Not yet recruiting

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 · Last updated 14 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
8 Apr 2026
Start date
1 May 2026
Primary completion date
31 May 2027
Lead sponsor
Assiut University
NCT number
NCT07529639

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 May 2026 to the primary completion date, 31 May 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who received neoadjuvant chemotherapy or radiotherapy.
  • History of prior or concurrent malignancy.

Other

  • Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma).
  • Cases with missing or inaccessible clinical follow-up data.

Who the study is looking for

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

Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.