Recruiting

En-bloc TURBT

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04235764

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

modified resectoscope

TURBT

Study Details

Brief summary:

Background:

Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.

Objective:

To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.

Eligibility:

People ages 18 and older who need to have their bladder removed at the NIH.

Design:

Participants will be screened with:

Medical and prior surgical history

Review of existing MRI, x-ray, or CT scans

Review of existing specimens and reports

Pregnancy test for women of childbearing age

CT or MRI: Participants will lie in a machine. The machine will take pictures of their body.

Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.

Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.

Conditions

Bladder Cancer

Study ID

NCT04235764

Start date

Sep 9, 2020

Status verified date

Aug 17, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Patients requiring surgical removal of the bladder at the NIH Clinical Center.

NOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments/or participating in other trials remain eligible for enrollment in this study.

  • Men and women
  • Age greater than or less than 18 years
  • Deemed clinically appropriate for the planned surgical procedure.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Subjects will be asked to co-enroll in 15-C-0087, "Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients." NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.

EXCLUSION CRITERIA:

\- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Bladder Cancer Patients

Interventions

modified resectoscope

The modified resectoscope will be used post cystectomy (En-bloc TURBT) to resect areas of the tumor from the cystectomy specimen. These resected tumors will be sent for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation and compared to the remainder of the cystectomy specimens to see if the modified resectoscope can provide improved pathologic standards for the TURBT procedure.

TURBT

All patients will receive routine surgical transurethral resection of bladder tumors (TURBT).

Primary outcome measure

  • Assessment of resectoscope device modification on pathologic standards for the TURBT procedure [ Time Frame: Time of surgery/pathologic assessment (7-10 days) ]

Central Contacts and Locations

Central contacts

NCI Medical Oncology Referral Office

(240) 760-6050ncimo_referrals@nih.gov

Raju R Chelluri, M.D.

(240) 858-3700raju.chelluri@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 8, 2026

Last verified

Aug 17, 2026

Keywords

  • TURBT
  • Transurethral Resection of Bladder Tumors
  • Cystectomy
  • Modified Resectoscope
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-08.