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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Mahmoud Laymon, MD,MRCS contact

01002275698

dr_mahmoudlaymon@mans.edu.eg

Ahmed elassmy, MD contact

a_assmy@yahoo.com

Egypt1 site, 1 recruiting
  • Urology and nephrology center, Mansoura University

    Al Mansurah, Dakahlia Governorate, 35516

    Ahmed Mosbah, MD, 01002275698, mosbah64@yahoo.com

    Recruiting

Other trials in Egypt

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.

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 groups in NCT05969964
Study groupRoleWhat they receive
Re_TURThose 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_TURThose 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.

  1. 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)
  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.

  1. First posted1 Aug 2023
  2. Study start1 Jul 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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