NCT02992990

Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade

A Prospective Study To Assess Whether A Preoperative Tumor Biopsy Can Improve Upon The Endoscopic Impression Determination Of Stage And Grade In Non-Muscle-Invasive Urothelial Carcinoma Of The Bladder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To assess whether the addition of a bladder tumor biopsy improves the level of agreement between the pretreatment endoscopic impression and the final postoperative pathology determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.

Detailed description

Non-invasive bladder cancer is challenging to treat because it is a condition characterized by frequent recurrences that lead to numerous invasive procedures for detection and treatment. The mainstay of therapy for non-muscle invasive bladder cancer, which has remained unchanged for decades, relies on surgical resection (TUR) associated with utilization of intravesical immunotherapy and chemotherapy. Despite our best efforts, these tumors continue to have suboptimal rates of recurrence and require long-term follow-up with costly and invasive procedures. The rationale for this study is to show that the preoperative biopsy, taken at the time of the office cystoscopic evaluation, improves pre-TUR staging and grading correlation with the final pathology of the resection. Indirectly, this will suggest that the routine use of pre-TUR biopsy provides more accurate information for intraoperative decision-making that can ultimately lead to better management of these patients with non-muscle-invasive bladder cancer.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Bladder tumor biopsy	Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.

Timeline

• Start date: 2018-04-01
• Primary completion: 2023-05-01
• Completion: 2023-12-01
• First posted: 2016-12-14
• Last updated: 2022-01-19

Locations

1 site across 1 country: United States