Clinical trial · Observational
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer
The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study
- 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 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: * Tumor-Stroma Ratio (TSR): The amount of tumor tissue compared to the surrounding supportive tissue. * Tumor-Infiltrating Lymphocytes (TILs): The number of immune cells that have moved into the tumor to try and fight it. * Tertiary Lymphoid Structures (TLS): Organized clusters of immune cells that form near the tumor. 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.
Conditions
Conditions (5)
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 Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Muscle-Invasive Urothelial Bladder Carcinoma | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Muscle-Invasive Urothelial Carcinoma Cohort
- description
- 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).
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From the date of radical cystectomy until the date of death from any cause, assessed up to 72 months (6 years).
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma. * Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024. 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