Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer

NCT07525349 | Not Yet Recruiting

• 1 other identifier: MIBC Immune-Stromal Landscape
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Keywords

Muscle-Invasive Bladder Cancer (MIBC); Urothelial Carcinoma; Radical Cystectomy; Tumor Microenvironment; Tumor-Stroma Ratio (TSR); Tumor-Infiltrating Lymphocytes (TILs); Tertiary Lymphoid Structures (TLS); Glasgow Microenvironment Score (GMS); Klintrup-Mäkinen (KM) Score

Outcome Measures

Primary Outcomes (1)

• 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).

  From the date of radical cystectomy until the date of death from any cause, assessed up to 72 months (6 years).

Study Arms (1)

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).

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.
• Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Tertiary Lymphoid Structures

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Pathology at South Egypt Cancer Institute, Assiut University

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04