Urothelial Bladder CarcinomaNCT07529639
Tumor Budding and T1 Substaging in Urothelial Bladder Cancer
An observational study of Urothelial Bladder Carcinoma and Bladder Carcinoma, run by Assiut University.
Trial summary
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Bladder Carcinoma, Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC)
- 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 diagnosed with urothelial bladder carcinoma who underwent transurethral resection (TUR) at the South Egypt Cancer Institute (SECI), Assiut University, between the years 2018 and 2024. The study utilizes retrospectively collected, archived paraffin-embedded tissue blocks along with corresponding clinical, pathological, and survival data retrieved from medical records and electronic pathology reports.
Who may be able to join
- Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.
- Patients with full clinical data and complete medical reports.
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: Assessment of Tumor Budding and T1 Substaging as Histopathological Predictors of Outcome in Urothelial Bladder Carcinoma
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).
Researchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.
Read more
The tissue samples will be analyzed in two main ways:
- Early-stage tumors (pT1 cases): Researchers will carefully measure the exact depth the tumor has invaded the bladder lining using anatomical and micrometric sub-classification systems.
- More advanced tumors (pT2 cases): Researchers will examine the invasive edge of the tumors under a microscope to count "tumor buds" (single cells or small clusters of cells).
By comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.
Read the detailed description
Bladder carcinoma remains a major global oncological burden, exerting a substantial impact on patient morbidity and mortality. In Egypt, it constitutes a significant public health concern with distinctive epidemiological characteristics. While squamous cell carcinoma historically predominated, a substantial shift has occurred over recent decades, and urothelial carcinoma has emerged as the dominant subtype, accounting for approximately 75-80% of cases.
Pathological assessment traditionally focuses on histological grade and invasion depth. The precise assessment of invasion depth is critical, particularly in T1 non-muscle-invasive urothelial carcinoma, where the tumor invades the lamina propria. Multiple sub-classification systems exist for T1 tumors, including anatomical approaches relative to the muscularis mucosae and semiquantitative micrometric methods, yet no single method has been adopted universally. Furthermore, in muscle-invasive disease, the morphology of the invasive front provides crucial biological insights. Tumor budding, defined as single isolated cancer cells or small clusters of fewer than five cells at the invasive front, is recognized as a morphological hallmark of epithelial-mesenchymal transition (EMT) and reflects aggressive tumor potential.
This study evaluates archived hematoxylin and eosin (H\&E)-stained slides from patients who underwent transurethral resection (TUR) for urothelial carcinoma between 2018 and 2024. Histological subtypes will be confirmed according to the 2022 World Health Organization (WHO) classification, and tumor grade and stage will be determined using the American Joint Committee on Cancer (AJCC) 8th edition. Additional pathological parameters assessed will include tumor size, multifocality, coagulative tumor necrosis, lympho-vascular invasion (LVI), and perineural invasion (PNI).
The histopathological procedures are divided into two primary evaluations:
- pT1 Substaging: Confirmed pT1 cases will undergo rigorous histopathological substaging. Anatomical substaging (T1a/b/c) will identify the invasion level relative to the muscularis mucosae. Micrometric assessment will utilize a 0.1 mm threshold for semi-quantitative subtyping, alongside the Rete Oncologica Lombarda (ROL) system, which uses a 1.0 mm threshold to define low-risk and high-risk progression groups.
- Tumor Budding Assessment: Confirmed pT2 cases will be evaluated for tumor budding at the invasive front using the "Hotspot" method to count buds in one high-power field. Cases will be stratified into three grades: Low Budding (BD1: 0-4 buds), Intermediate Budding (BD2: 5-9 buds), and High Budding (BD3: ≥ 10 buds).
- Conditions
- Urothelial Bladder Carcinoma, Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Cancer (MIBC)
- Keywords
- Tumor Budding, T1 Substaging, Histopathology, Disease Progression, Survival Outcomes, Transurethral Resection (TUR), Epithelial-Mesenchymal Transition (EMT), Invasion Depth
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Disease Progression
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 |
|---|---|---|
| pT1 Urothelial Carcinoma Cases | All confirmed pT1 cases will undergo rigorous histopathological substaging. An anatomical substaging (T1a/b/c) will be performed by identifying the level of invasion relative to the muscularis mucosae. Additionally, micrometric assessment will be carried out using a 0.1 mm threshold and the Rete Oncologica Lombarda (ROL) system. | |
| pT2 Urothelial Carcinoma Cases | These cases will be evaluated for Tumor Budding. The "Hotspot" method will be used to count buds in one high power field at the invasive front. Cases will be graded as Low Budding (BD1): 0-4 buds, Intermediate Budding (BD2): 5-9 buds, and High Budding (BD3): ≥ 10 buds. |
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 the transurethral resection (TUR) to the date of death from any cause. This outcome will be correlated with the assessed histopathological parameters (T1 substaging and Tumor Budding scores) to evaluate their prognostic significance in urothelial bladder carcinoma.
Measured: Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 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 Urothelial 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, Hasnaa Usama Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529639
- Sponsor's protocol ID
- T1 & Budding in Bladder Cancer
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tumor Budding and T1 Substaging as Histopathological Predictors of Outcome in Urothelial Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT07529639
- Acronym / sponsor ID
- T1 & Budding in Bladder Cancer
- Conditions
- Urothelial Bladder Carcinoma, Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Cancer (MIBC)
- Keywords
- Tumor Budding, T1 Substaging, Histopathology, Disease Progression, Survival Outcomes, Transurethral Resection (TUR), Epithelial-Mesenchymal Transition (EMT), Invasion Depth
- 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
- 14 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 and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).
Researchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.
The tissue samples will be analyzed in two main ways:
- Early-stage tumors (pT1 cases): Researchers will carefully measure the exact depth the tumor has invaded the bladder lining using anatomical and micrometric sub-classification systems.
- More advanced tumors (pT2 cases): Researchers will examine the invasive edge of the tumors under a microscope to count "tumor buds" (single cells or small clusters of cells).
By comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.
Detailed description
Bladder carcinoma remains a major global oncological burden, exerting a substantial impact on patient morbidity and mortality. In Egypt, it constitutes a significant public health concern with distinctive epidemiological characteristics. While squamous cell carcinoma historically predominated, a substantial shift has occurred over recent decades, and urothelial carcinoma has emerged as the dominant subtype, accounting for approximately 75-80% of cases.
Pathological assessment traditionally focuses on histological grade and invasion depth. The precise assessment of invasion depth is critical, particularly in T1 non-muscle-invasive urothelial carcinoma, where the tumor invades the lamina propria. Multiple sub-classification systems exist for T1 tumors, including anatomical approaches relative to the muscularis mucosae and semiquantitative micrometric methods, yet no single method has been adopted universally. Furthermore, in muscle-invasive disease, the morphology of the invasive front provides crucial biological insights. Tumor budding, defined as single isolated cancer cells or small clusters of fewer than five cells at the invasive front, is recognized as a morphological hallmark of epithelial-mesenchymal transition (EMT) and reflects aggressive tumor potential.
This study evaluates archived hematoxylin and eosin (H\&E)-stained slides from patients who underwent transurethral resection (TUR) for urothelial carcinoma between 2018 and 2024. Histological subtypes will be confirmed according to the 2022 World Health Organization (WHO) classification, and tumor grade and stage will be determined using the American Joint Committee on Cancer (AJCC) 8th edition. Additional pathological parameters assessed will include tumor size, multifocality, coagulative tumor necrosis, lympho-vascular invasion (LVI), and perineural invasion (PNI).
The histopathological procedures are divided into two primary evaluations:
- pT1 Substaging: Confirmed pT1 cases will undergo rigorous histopathological substaging. Anatomical substaging (T1a/b/c) will identify the invasion level relative to the muscularis mucosae. Micrometric assessment will utilize a 0.1 mm threshold for semi-quantitative subtyping, alongside the Rete Oncologica Lombarda (ROL) system, which uses a 1.0 mm threshold to define low-risk and high-risk progression groups.
- Tumor Budding Assessment: Confirmed pT2 cases will be evaluated for tumor budding at the invasive front using the "Hotspot" method to count buds in one high-power field. Cases will be stratified into three grades: Low Budding (BD1: 0-4 buds), Intermediate Budding (BD2: 5-9 buds), and High Budding (BD3: ≥ 10 buds).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pT1 Urothelial Carcinoma Cases | – | –All confirmed pT1 cases will undergo rigorous histopathological substaging. An anatomical substaging (T1a/b/c) will be performed by identifying the level of invasion relative to the muscularis mucosae. Additionally, micrometric assessment will be carried out using a 0.1 mm threshold and the Rete Oncologica Lombarda (ROL) system. |
| pT2 Urothelial Carcinoma Cases | – | –These cases will be evaluated for Tumor Budding. The "Hotspot" method will be used to count buds in one high power field at the invasive front. Cases will be graded as Low Budding (BD1): 0-4 buds, Intermediate Budding (BD2): 5-9 buds, and High Budding (BD3): ≥ 10 buds. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients diagnosed with urothelial bladder carcinoma who underwent transurethral resection (TUR) at the South Egypt Cancer Institute (SECI), Assiut University, between the years 2018 and 2024. The study utilizes retrospectively collected, archived paraffin-embedded tissue blocks along with corresponding clinical, pathological, and survival data retrieved from medical records and electronic pathology reports.
Key inclusion criteria (2 listed)
- Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.
- Patients with full clinical data and complete medical reports.
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: Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).
Overall survival is defined as the length of time from the date of the transurethral resection (TUR) to the date of death from any cause. This outcome will be correlated with the assessed histopathological parameters (T1 substaging and Tumor Budding scores) to evaluate their prognostic significance in urothelial bladder carcinoma.
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 14 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 Urothelial Bladder Carcinoma and Bladder Carcinoma, 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 14 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: Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).). 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 14 Apr 2026.