Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins

NCT05969964 | Recruiting DMC

• 1 other identifier: MS.23.06.2435
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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 bladder cancer treated with ERBT and intravesical BCG through a RCT.

Conditions

Bladder Cancer Stage I

Outcome Measures

Primary Outcomes (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

  12 month

Secondary Outcomes (1)

• perioperative complications associated with re TURBT

  12 month

Other Outcomes (1)

• The financial cost associated with performing repeat resection.

  12 months

Study Arms (2)

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.

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

Behavioral: Avoid second resection after initial complete resection

Interventions

Avoid second resection after initial complete resection BEHAVIORAL

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.

No re_TUR; Re_TUR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.

You may qualify if:

• Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder tumor tissues resected during cystoscopy

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Mahmoud Laymon, MD,MRCS

  Urology &Nephrology Center, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Laymon, MD,MRCS

CONTACT

01002275698; dr_mahmoudlaymon@mans.edu.eg

Ahmed elassmy, MD

CONTACT

a_assmy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 1, 2023
• Study Start: July 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

EG (1)