Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)NCT07642102
Evaluation of the Role of Early Second Look TURBT in Management of High Risk Non Muscle Invasive Bladder Cancer
An observational study of Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) and Transurethral Resection of Bladder Tumor, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim is to evaluate the intraoperative, postoperative and pathologic findings of early second look TURBT and the factors affecting these findings to assess the value of early second TURBT in the management of high risk NMIBC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Transurethral Resection of Bladder Tumor
- What is being tested?
- early second look transurethral resection of bladder tumor
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2025to 22 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent initial complete transurethral resection of bladder tumor with high risk non muscle invasive bladder cancer, recruited from the urology outpatient clinic, Urology department, Ain shams University.
Who may be able to join
- patients underwent initial complete resection TURBT with high risk non muscle invasive bladder cancer including: High grade T1 Any carcinoma in situ Any recurrent high grade Ta High grade Ta tumor size is more than 3 cm Any BCG failure in high grade patient Any variant histology Lymphovascular invasion High grade prostatic urethral involvement
Who cannot join
- - Low risk non muscle invasive bladder cancer
- intermediate risk non muscle invasive bladder cancer
- muscle invasive bladder cancer
- metastatic bladder cancer (positive lymph nodes or distant metastasis )
- absent muscle layer in the initial TURBT biopsies
- incomplete resection initial TURBT
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to evaluate the intraoperative, postoperative and pathologic findings of early second look TURBT and the factors affecting these findings to assess the value of early second TURBT in the management of high risk NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Transurethral Resection of Bladder Tumor
- Being tested
- early second look transurethral resection of bladder tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early second look transurethral resection of bladder tumorProcedure or surgery
endoscopic early second look transurethral resection of bladder tumor after initial complete resection transurethral resection of non muscle invasive bladder tumor
| Study group | Role | What they receive |
|---|---|---|
| patients with non muscle invasive bladder cancer after transurethral resection of bladder tumor | Not described Receives: Procedure: early second look transurethral resection of bladder tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of pathologically positive tumor
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start2 May 2025
- Primary completion30 Oct 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642102
- Sponsor's protocol ID
- FMASU MS 311/2025
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Early Second Look TURBT in Management of High Risk Non Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07642102
- Acronym / sponsor ID
- FMASU MS 311/2025
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Transurethral Resection of Bladder Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 11 Jun 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.
The aim is to evaluate the intraoperative, postoperative and pathologic findings of early second look TURBT and the factors affecting these findings to assess the value of early second TURBT in the management of high risk NMIBC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with non muscle invasive bladder cancer after transurethral resection of bladder tumor | – | Procedure: early second look transurethral resection of bladder tumor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent initial complete transurethral resection of bladder tumor with high risk non muscle invasive bladder cancer, recruited from the urology outpatient clinic, Urology department, Ain shams University.
Key inclusion criteria (1 listed)
- patients underwent initial complete resection TURBT with high risk non muscle invasive bladder cancer including: High grade T1 Any carcinoma in situ Any recurrent high grade Ta High grade Ta tumor size is more than 3 cm Any BCG failure in high grade patient Any variant histology Lymphovascular invasion High grade prostatic urethral involvement
Key exclusion criteria (6 listed)
- - Low risk non muscle invasive bladder cancer
- intermediate risk non muscle invasive bladder cancer
- muscle invasive bladder cancer
- metastatic bladder cancer (positive lymph nodes or distant metastasis )
- absent muscle layer in the initial TURBT biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early second look transurethral resection of bladder tumorendoscopic early second look transurethral resection of bladder tumor after initial complete resection transurethral resection of non muscle invasive bladder tumor | Procedure or surgery | patients with non muscle invasive bladder cancer after transurethral resection of bladder tumor |
Primary outcome
presence of pathologically positive tumor
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
Not yet recruitingPhase 3
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) and Transurethral Resection of Bladder Tumor, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
presence of pathologically positive tumor (time frame: 6 weeks). 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 11 Jun 2026.