Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer

Sponsor
Assiut University
Study ID
NCT07525349
Status
Not Yet Recruiting

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Conditions

  • Bladder Cancer
  • Muscle-Invasive Bladder Carcinoma
  • Muscle-Invasive Urothelial Bladder Carcinoma
  • Urinary Bladder Neoplasms
  • Urothelial Carcinoma (UC)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Muscle-Invasive Urothelial Carcinoma Cohort
    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 Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of radical cystectomy until the date of death from any cause, assessed up to 72 months (6 years). ]

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