Skipping BCG for T1a Urinary Bladder Tumor.

NCT ID: NCT04298073

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2022-04-04

Brief Summary

Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .

Detailed Description

Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .

Conditions

Superficial Bladder Cancer t1a

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• The study will include all patients that diagnosed for the first time as T1a urothelial carcinoma .

Exclusion Criteria

1. Other variants of bladder cancer as squamous cell carcinoma of urinary bladder ,small cell carcinoma of urinary bladder, -sarcomatoid variant of urinary bladder & anaplastic cell carcinoma of urinary bladder

2. patients Who were previously treated for bladder cancer by any modality including TURT, BCG, chemotherapy and radiotherapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Ali Hamed

dr Ahmed ali

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed M Ali, MD

Role: CONTACT

ahmedali-61988@hotmail.com

01008181914

Other Identifiers

new treatment bladder cancer

Identifier Type: -

Identifier Source: org_study_id