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

NCT02992990 | Unknown DMC

• 1 other identifier: H-40414
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bladder tumor biopsy

OTHER

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

Procedure: Bladder tumor biopsy

Interventions

Bladder tumor biopsy PROCEDURE

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

Bladder tumor biopsy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant or lactating women.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Guillherme Godoy, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Harrison

CONTACT

713-798-2240; sharons@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 14, 2016
• Study Start: April 1, 2018
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)