Recruiting

Bladder Tumor Biopsy

Sponsor:

Baylor College of Medicine

Code:

NCT02992990

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Bladder tumor biopsy

Study Details

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

Study ID

NCT02992990

Start date

Apr 1, 2018

Status verified date

Jan, 2022

Completion date

Dec 1, 2023

Anticipated

Primary completion date

May 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Bladder tumor biopsy

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

Interventions

Bladder tumor biopsy

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

Primary outcome measure

  • Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Sharon Harrison

713-798-2240sharons@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Guilherme Godoy, MD

713-798-4001godoy@bcm.edu

Principal Investigator:

Guilherme Godoy, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jan 19, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2022-01-19.