Clinical outcomes in non-muscle invasive bladder cancer: A global multisite chart review study

• Conditions: ON-MUSCLE INVASIVE BLADDER CANCER; C67; Malignant neoplasm of bladder

• Registration Number: DRKS00020117
• Lead Sponsor: Merck Sharp & Dohme Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-19
• Study Completion: 2020-12-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

histologically-confirmed diagnosis of high risk non-muscle-invasive (T1 [any grade], high grade Ta and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant histology)

Exclusion Criteria

Muscle-invasive, locally advanced nonresectable, or metastatic urothelialcarcinoma (i.e., T2, T3, T4, and / or stage IV) at index date

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collected will be data for the period 2011-2018 real-world NMIBC (non-muscle invasive bladder cancer). The primary outcomes will include real-world complete response rate and real-world disease-free survival.<br>These outcomes will be assessed using high quality real world data as per urine cytology, cystoscopy, and/or biopsy and imaging (CTU) and associated clinical data.

Secondary Outcome Measures

Name	Time	Method
overall survival, real-world time to cystectomy.