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BRIEF TITLE: 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

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


  • Org Study ID: H-40414
  • Secondary ID:
  • NCT ID: NCT02992990
  • NCT Alias:
  • Sponsor: Baylor College of Medicine - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting April 1, 2018 N/A 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 - Time Frame: 3 years

Condition:

  • Bladder Cancer

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.
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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: Sharon Harrison

Phone: 713-798-2240

Email: sharons@bcm.edu

Location

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