An observational study in Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC) and Bladder Cancer, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Assiut University · Observational
Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy). However, even after surgery, it can be difficult for doctors to accurately predict how an individual patient's disease will progress using standard staging methods.
This retrospective observational study aims to find better ways to predict patient outcomes by examining the tumor microenvironment, which is the environment immediately surrounding the cancer cells. Specifically, researchers are looking at the relationship between the tumor cells, the surrounding supportive tissue (the stroma), and the patient's natural immune cells.
The study will review existing medical records and archived tumor tissue samples from at least 100 patients who underwent radical cystectomy at the South Egypt Cancer Institute between 2018 and 2024. Under a microscope, researchers will assess three main features:
By analyzing these features, the researchers hope to determine if specific patterns of immune and supportive cells are linked to better or worse survival rates, such as Overall Survival and Disease-Free Survival. Understanding this immune-stromal landscape could lead to more personalized risk assessments and better treatment plans for future bladder cancer patients.
Urothelial carcinoma is the predominant histological type of bladder cancer, representing about 90% of cases. In Egypt, a substantial shift in histopathological patterns has been observed over recent decades, with urothelial carcinoma emerging as the dominant subtype over squamous cell carcinoma. The clinical outcome of bladder cancer is influenced by established prognostic factors such as tumor stage and histological grade. However, these parameters are frequently unable to fully capture the biological heterogeneity of the disease, limiting their ability to accurately predict individual patient outcomes.
This limitation has prompted interest in identifying additional prognostic markers within the tumor microenvironment. Morphological and immune-related parameters are increasingly recognized as valuable indicators of tumor aggressiveness and epithelial-mesenchymal transition.
To investigate this, histopathological assessment will be performed on the representative slide for each patient featuring the deepest invasion, highest tumor grade, and minimal necrosis. Tumor grade and pathological stage will be determined based on the American Joint Committee on Cancer (AJCC) staging system (8th edition), and histological subtypes will be confirmed according to the 2022 World Health Organization (WHO) classification. Additional parameters to be assessed include coagulative tumor necrosis, surgical margin status, lymph node metastasis, lymphovascular invasion (LVI), and perineural invasion (PNI).
The study will strictly evaluate the following morpho-immune parameters:
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This study's planned enrollment of 100 is below the median of 200 across 123 observational studies indexed under Carcinoma, Transitional Cell.
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The study population consists of patients who underwent radical cystectomy for muscle invasive urothelial carcinoma at the South Egypt Cancer Institute (SECI) between 2018 and 2024.
Exclusion Criteria:
This cohort consists of patients who underwent radical cystectomy for muscle-invasive urothelial carcinoma at the South Egypt Cancer Institute (SECI) between 2018 and 2024. Patients are excluded if they had non-urothelial histological subtypes, received neoadjuvant chemotherapy or radiotherapy, had a history of prior or concurrent malignancy, or lack accessible clinical follow-up data. Archived hematoxylin and eosin (H\&E)-stained slides from this cohort will be retrospectively evaluated for morphological and immune-related parameters, specifically Tumor-Stroma Ratio (TSR), Tumor-Infiltrating Lymphocytes (TILs), and Tertiary Lymphoid Structures (TLS).
Overall Survival (OS)
Overall survival is defined as the length of time from the date of radical cystectomy to the date of death from any cause. This measure will be used to evaluate the prognostic significance of tumor microenvironment parameters, including the tumor-stroma ratio (TSR), tumor-infiltrating lymphocytes (TILs), and tertiary lymphoid structures (TLS).
Time frame: From the date of radical cystectomy until the date of death from any cause, assessed up to 72 months (6 years).
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Assiut University