Muscle-Invasive Bladder CarcinomaNCT07525349
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer
An observational study of Muscle-Invasive Bladder Carcinoma and Urothelial Carcinoma (UC), run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC), Bladder Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.
- Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.
Who cannot join
- 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.
About this study
Official title: The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study
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.
Read more
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.
Read the detailed description
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:
- Tumor-Stroma Ratio (TSR): TSR will be assessed at the invasive tumor front using a standardized scoring system. Tumors will be classified into two categories: stroma-high (> 50% stromal component) and stroma-low (≤ 50% stromal component).
- Tumor-Infiltrating Lymphocytes (TILs): The density of TILs will be evaluated on H\&E-stained sections using the semi-quantitative Klintrup-Mäkinen (KM) scoring system. The immune response will be categorized into four grades (0-3), which will be further stratified into low-grade (0-1) and high-grade (2-3) immune responses.
- Tertiary Lymphoid Structures (TLS): TLSs will be histologically evaluated focusing on the tumor's invasive edge. The evaluation is based on three quantitative parameters: average density, hotspot density, and maximal diameter.
- Glasgow Microenvironment Score (GMS): This simplified prognostic tool evaluates the tumor microenvironment by integrating the KM grade and the TSR to stratify patients into three prognostic groups. The GMS Grading Scale will assign patients to GMS 0 (high-grade inflammatory response), GMS 1 (low-grade inflammatory response with low stromal percentage), or GMS 2 (low-grade inflammatory response with a high stromal percentage).
- 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
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the date of radical cystectomy until the date of death from any cause, assessed up to 72 months (6 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Adel Ali Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525349
- Sponsor's protocol ID
- MIBC Immune-Stromal Landscape
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study
- ClinicalTrials.gov ID
- NCT07525349
- Acronym / sponsor ID
- MIBC Immune-Stromal Landscape
- 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)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Tumor-Stroma Ratio (TSR): TSR will be assessed at the invasive tumor front using a standardized scoring system. Tumors will be classified into two categories: stroma-high (> 50% stromal component) and stroma-low (≤ 50% stromal component).
- Tumor-Infiltrating Lymphocytes (TILs): The density of TILs will be evaluated on H\&E-stained sections using the semi-quantitative Klintrup-Mäkinen (KM) scoring system. The immune response will be categorized into four grades (0-3), which will be further stratified into low-grade (0-1) and high-grade (2-3) immune responses.
- Tertiary Lymphoid Structures (TLS): TLSs will be histologically evaluated focusing on the tumor's invasive edge. The evaluation is based on three quantitative parameters: average density, hotspot density, and maximal diameter.
- Glasgow Microenvironment Score (GMS): This simplified prognostic tool evaluates the tumor microenvironment by integrating the KM grade and the TSR to stratify patients into three prognostic groups. The GMS Grading Scale will assign patients to GMS 0 (high-grade inflammatory response), GMS 1 (low-grade inflammatory response with low stromal percentage), or GMS 2 (low-grade inflammatory response with a high stromal percentage).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.
- Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma and Urothelial Carcinoma (UC), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.