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

NCT ID: NCT02992990

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-12-01

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Bladder tumor biopsy

All subjects will undergo a bladder tumor biopsy followed by transurethral resection.

Group Type: OTHER

Bladder tumor biopsy

Intervention Type: PROCEDURE

Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.

Interventions

Bladder tumor biopsy

Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Godoy

Assistant Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillherme Godoy, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharon Harrison

Role: CONTACT

sharons@bcm.edu

713-798-2240

Facility Contacts

Guilherme Godoy, MD

Role: primary

godoy@bcm.edu

713-798-4001

Other Identifiers

H-40414

Identifier Type: -

Identifier Source: org_study_id