Bladder Cancer Stage INCT05969964
Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins
An observational study of Bladder Cancer Stage I, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this [ Can second resection for pT1 bladder carcinoma be safely avoided after initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess the impact of avoiding re TUR on Recurrence free survival, progression free survival and cancer specific survival in patients with pT1… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer Stage I
- What is being tested?
- Avoid second resection after initial complete resection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.
Who may be able to join
- Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.
Who cannot join
- Large tumors not suitable for ERBT
- Residual tumor.
- Multicentric tumors ( more than 4 lesions)
- Presence of CIS.
- Positive vertical or horizontal safety margins after initial resection.
Trial locations and contacts
1 site in 1 country.
Ahmed elassmy, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Urology and nephrology center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Ahmed Mosbah, MD, 01002275698, mosbah64@yahoo.com
About this study
Official title: Can Second Resection for pT1 Bladder Carcinoma be Safely Avoided After Initial En-Bloc Resection With Negative Vertical and Horizontal Safety Margins: A Randomized Controlled Trial
The goal of this [ Can second resection for pT1 bladder carcinoma be safely avoided after initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess the impact of avoiding re TUR on Recurrence free survival, progression free survival and cancer specific survival in patients with pT1 bladder cancer treated with ERBT and intravesical BCG through a RCT.
Read the detailed description
Bladder cancer (BC) is the one of the most prevalent cancer in Egypt representing nearly 30% of all cancers. Approximately 75% of newly diagnosed BC present with non-muscle invasive disease (NMIBC). Initial treatment for most BCs includes transurethral resection (TUR) of the tumor to obtain tissues sufficient for histo-pathological examination to determine if the tumor reaches the muscular proprietary or not.
In the setting of non muscle invasive urothelial carcinoma (NMIBC) especially T1HG, several studies showed a benefit of performing repeat resection within 2- 6 weeks to ensure adequate resection and exclude invasion of muscle layer.
However, several issues make this recommendation ie. Re-TUR at least debatable . First, most of these recommendations are based on heterogenous studies that didn't report cancer specific survival (CSS). The risk of upstaging to muscle-invasive disease at re-TUR i did not exceed 7% in recent series . Moreover, the potential complications of re TUR that include bladder perforation and extravasation may delay administration of intravesical BCG and this delay is associated with increased risk of tumor recurrence and progression.
On the other hand, several studies have demonstrated that presence of detrusor muscle (DM) in the initial specimen is a surrogate marker of resection quality and was associated with less incidence of residual tumor at the re TUR. New techniques like En-bloc resection of bladder tumour (ERBT) entails a circumferential incision around the tumor with 5-10 mm safety margin, then proceed to deep muscle layer underneath the tumor where it is dissected using a combination of blunt dissection and laser or diathermy energy. This technique allows accurate assessment of the depth of invasion and the infiltration pattern of NMIBC and thus improving the accuracy of pathological diagnosis.
Recently published articles on this topic reported a higher rate of detrusor muscle in the specimen (96%) with enbloc compared to conventional TURB.
In a retrospective analysis of 106 patients with pT1 bladder cancer treated with ERBT, 50 patients underwent re-TUR and no significant benefits in terms of RFS and PFS to performing a reTUR in all patients with pT1 on initial ERBT.
Residual tumors were found in 6 patients (12%) and none of them were upstaged to T2 disease. Interestingly, no residual disease or recurrence overtime at the initial ERBT site in patients with negative horizontal safety margins and residual tumor was found in 2 out of 45 patients with negative vertical safety margins
Aim of Work
The aim of this study is to assess the impact of avoiding re TUR after initial enbloc resection of primary tumor with negative safety margins on recurrence free survival (RFS) ,progression free survival (PFR) and cancer specific survival (CSS ) in patients with pT1 bladder cancer through a RCT.
- Conditions
- Bladder Cancer Stage I
- Being tested
- Avoid second resection after initial complete resection
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avoid second resection after initial complete resectionBehavioural
Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Re_TUR | Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins will undergo second look as endorsed by the guidelines. Receives: Behavioral: Avoid second resection after initial complete resection | |
| No re_TUR | Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines and will receive directly intravesical BCG Receives: Behavioral: Avoid second resection after initial complete resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of avoiding repeat resection on recurrence and progression free survival.
occurrence of new tumors or progression of the primary tumor will be compared between both groups. Tis will be assessed by both cystoscopy and MRI findings
Measured: 12 month
Secondary outcomes (1)
perioperative complications associated with re TURBT
The incidence of perioperative complications after repeat resection will be documented and compared between both groups. This outcome will be assessed using Dindo-Clavien classification.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Stage IStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Laymon, MD,MRCS, Principal investigator, Urology &Nephrology Center, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969964
- Sponsor's protocol ID
- MS.23.06.2435
- Status last verified
- Oct 2024
- First submitted
- 3 Jul 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Second Resection for pT1 Bladder Carcinoma be Safely Avoided After Initial En-Bloc Resection With Negative Vertical and Horizontal Safety Margins: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05969964
- Acronym / sponsor ID
- MS.23.06.2435
- Conditions
- Bladder Cancer Stage I
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (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 goal of this [ Can second resection for pT1 bladder carcinoma be safely avoided after initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess the impact of avoiding re TUR on Recurrence free survival, progression free survival and cancer specific survival in patients with pT1 bladder cancer treated with ERBT and intravesical BCG through a RCT.
Detailed description
Bladder cancer (BC) is the one of the most prevalent cancer in Egypt representing nearly 30% of all cancers. Approximately 75% of newly diagnosed BC present with non-muscle invasive disease (NMIBC). Initial treatment for most BCs includes transurethral resection (TUR) of the tumor to obtain tissues sufficient for histo-pathological examination to determine if the tumor reaches the muscular proprietary or not.
In the setting of non muscle invasive urothelial carcinoma (NMIBC) especially T1HG, several studies showed a benefit of performing repeat resection within 2- 6 weeks to ensure adequate resection and exclude invasion of muscle layer.
However, several issues make this recommendation ie. Re-TUR at least debatable . First, most of these recommendations are based on heterogenous studies that didn't report cancer specific survival (CSS). The risk of upstaging to muscle-invasive disease at re-TUR i did not exceed 7% in recent series . Moreover, the potential complications of re TUR that include bladder perforation and extravasation may delay administration of intravesical BCG and this delay is associated with increased risk of tumor recurrence and progression.
On the other hand, several studies have demonstrated that presence of detrusor muscle (DM) in the initial specimen is a surrogate marker of resection quality and was associated with less incidence of residual tumor at the re TUR. New techniques like En-bloc resection of bladder tumour (ERBT) entails a circumferential incision around the tumor with 5-10 mm safety margin, then proceed to deep muscle layer underneath the tumor where it is dissected using a combination of blunt dissection and laser or diathermy energy. This technique allows accurate assessment of the depth of invasion and the infiltration pattern of NMIBC and thus improving the accuracy of pathological diagnosis.
Recently published articles on this topic reported a higher rate of detrusor muscle in the specimen (96%) with enbloc compared to conventional TURB.
In a retrospective analysis of 106 patients with pT1 bladder cancer treated with ERBT, 50 patients underwent re-TUR and no significant benefits in terms of RFS and PFS to performing a reTUR in all patients with pT1 on initial ERBT.
Residual tumors were found in 6 patients (12%) and none of them were upstaged to T2 disease. Interestingly, no residual disease or recurrence overtime at the initial ERBT site in patients with negative horizontal safety margins and residual tumor was found in 2 out of 45 patients with negative vertical safety margins
Aim of Work
The aim of this study is to assess the impact of avoiding re TUR after initial enbloc resection of primary tumor with negative safety margins on recurrence free survival (RFS) ,progression free survival (PFR) and cancer specific survival (CSS ) in patients with pT1 bladder cancer through a RCT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re_TUR | – | Behavioral: Avoid second resection after initial complete resectionThose patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins will undergo second look as endorsed by the guidelines. |
| No re_TUR | – | Behavioral: Avoid second resection after initial complete resectionThose patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines and will receive directly intravesical BCG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.
Key inclusion criteria (1 listed)
- Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.
Key exclusion criteria (5 listed)
- Large tumors not suitable for ERBT
- Residual tumor.
- Multicentric tumors ( more than 4 lesions)
- Presence of CIS.
- Positive vertical or horizontal safety margins after initial resection.
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 |
|---|---|---|
| Avoid second resection after initial complete resectionThose patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines. | Behavioural | No re_TUR, Re_TUR |
Primary outcome
Impact of avoiding repeat resection on recurrence and progression free survival.
Time frame: 12 month
occurrence of new tumors or progression of the primary tumor will be compared between both groups. Tis will be assessed by both cystoscopy and MRI findings
1 secondary outcome
perioperative complications associated with re TURBT
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ahmed elassmy, MD contact
Mahmoud Laymon, MD,MRCS principal investigator
Urology &Nephrology Center, Mansoura University, Egypt
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 Cancer Stage I, run by Mansoura 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 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Laymon, MD,MRCS (01002275698, dr_mahmoudlaymon@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of avoiding repeat resection on recurrence and progression free survival. (time frame: 12 month). 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 30 Oct 2024.