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

Primary Purpose

Bladder Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bladder tumor biopsy

About this trial

This is an interventional other trial for Bladder Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bladder tumor biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02992990

First Posted

December 8, 2016

Last Updated

January 14, 2022

Sponsor

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02992990

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bladder tumor biopsy

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Bladder tumor biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sharon Harrison

Phone

713-798-2240

sharons@bcm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillherme Godoy, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guilherme Godoy, MD

Phone

713-798-4001

godoy@bcm.edu

First Name & Middle Initial & Last Name & Degree

Guilherme Godoy, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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