Bladder Cancer Clinical Trial
Official title:
Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?
The primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (aged >18 years) - Patients with primary or recurrent NMIBC for whom complete primary TURBT was done. Exclusion Criteria: - Patients with incomplete resection - Patients with nonurothelial carcinoma or variant histology. - Patient with biopsy proven muscle invasion, or Ta BC. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura Urology and Nephrology Center | Mansoura | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of positive repeat biopsy for malignancy | The primary outcome include evaluation of the clinical performance of combined urine cytology and outpatient check cystoscopy 4 weeks after primary complete resection of T1BC as a predictive tool for possible residual malignancy at repeat biopsy. | 4 weeks | |
Secondary | Tumor recurrence rate | The secondary outcome includes the evaluation of predictive capacity of combined urine cytology and outpatient check cystoscopy for early tumor recurrence in the study participants. | 1 year |
Status | Clinical Trial | Phase | |
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