CClinicalTrials.gg
Status unknownNCT04298073Updated Mar 6, 2020

Skipping BCG for T1a Urinary Bladder Tumor.

An observational study in Superficial Bladder Cancer t1a, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
43
Sex
All
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Superficial Bladder Cancer t1a
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 43 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

all patients who attending our oncological urology outpatient clinic consented to participate in the study.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
43 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. follow up

    evaluation if there is recurrence or progression of T1a bladder tumor.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04298073
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Ali Hamed (dr Ahmed ali, Assiut University) — Principal investigator
First posted
Mar 6, 2020
Start date
Mar 4, 2020 (estimated)
Primary completion
Mar 4, 2022 (estimated)
Completion
Apr 4, 2022 (estimated)
Last update
Mar 6, 2020

Study contacts

Ahmed M Ali, MD
Contact
ahmedali-61988@hotmail.com
01008181914

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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