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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: Bladder tumor biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or females, age 21 or older; Clinical evidence of urothelial carcinoma of the bladder; Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or multiple, at initial occurrence or recurrent with >12 months interval free of disease; Surgically eligible for the TUR; Patient or authorized proxy needs to have signed the informed consent form. Exclusion Criteria: History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher); Patients with sessile appearing bladder tumors, which may be T2 or higher stage; Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract; Concurrent use of anticoagulation medication or chronic use of NSAIDs, including aspirin (other than cardio protective doses of 80mg daily) that has not been appropriately interrupted before the office cystoscopic evaluation; Patient deemed medically or psychologically unfit for the surgical procedure; Subject has received any investigational medication within 30 days prior to the registration or is scheduled to receive an investigational drug during the course of the study; Women Exclusion Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bladder tumor biopsy<br>All subjects will undergo a bladder tumor biopsy followed by transurethral resection. | Procedure: Bladder tumor biopsy<br>* Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors. | Assessment of grade, which is the main endpoint will be dichotomous defining lesions between low versus high grade. Stage classification of non-muscle-invasive papillary lesions is also dichotomous between Ta and T1 lesions. CIS can be annotated, but since these are flat, diffuse and non resectable in the bladder, they are not part of our main analysis, endpoints, or sample size calculations. The only exception is when the presence of CIS is used to determine grade (high-grade lesion). | 3 years |