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

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

INTRODUCTION

  • Org Study ID: H-40414
  • Secondary ID: N/A
  • NTC ID: NCT02992990
  • Sponsor: Baylor College of Medicine

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.

  • Overall Status
    Recruiting
  • Start Date
    April 1, 2018
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.

Primary Outcome 1 - Timeframe: 3 years

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Guillherme Godoy, MD

Role: Principal Investigator

Affiliation: Baylor College of Medicine

Overall Contact

Name: Guillherme Godoy, MD

Phone: 713-798-2240

Email: sharons@bcm.edu

LOCATION

Facility Status Contact
Facility: Baylor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Guilherme Godoy, MD
713-798-4001
godoy@bcm.edu