En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

NCT ID: NCT04235764

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2027-09-30

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.

Detailed Description

Background:

• Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women.
• The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT).
• TURBT requires the fragmentation of bladder tumors and piecemeal removal of these tumors.
• TURBT leads to loss of histopathologic information - including tumor orientation, size, and margin status - which may compromise outcomes and risk tumor seeding within the bladder.
• Given these multiple problems with TURBT we are testing some modifications to the current resectoscope device and the effect of these modifications on the quality of TURBT specimens produced.
• The redesigned resectoscope device will be tested ex-vivo on cystectomy specimens to avoid risks to patient safety.

Objectives:

The primary objective of this study is to determine if resectoscope device modification can provide improved pathologic standards for the TURBT procedure. An improvement in any of the parameters outlined below will constitute a device improvement in the current resectoscope:

• Presence of three tissue layers within the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.
• Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.

Eligibility:

• Medical condition requiring surgical removal of the bladder
• Men and women, age >= 18 years

Design:

• Preclinical tissue acquisition trial, ex vivo, proof-of-concept.
• Following cystectomy, a modified resectoscope/redesigned resectoscope will be used to resect areas of tumor from the cystectomy specimens. These resected tumors will be sent with the cystectomy specimen for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation.
• The remainder of the cystectomy specimens will undergo traditional histopathology. Histopathologic information from both specimens will be included in the final histopathologic diagnosis to ensure accurate oncology staging.
• This study will allow for about 2 years of accrual and the accrual ceiling will be set at 25 subjects.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1/ Cohort 1

Bladder Cancer Patients

modified resectoscope

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

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

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.

Intervention Type: DEVICE

TURBT

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raju R Chelluri, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

NCI Medical Oncology Referral Office

Role: CONTACT

ncimo_referrals@nih.gov

(240) 760-6050

Raju R Chelluri, M.D.

Role: CONTACT

raju.chelluri@nih.gov

(240) 858-3700

Facility Contacts

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

Role: primary

888-624-1937

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-C-0020.html

NIH Clinical Center Detailed Web Page

Other Identifiers

20-C-0020

Identifier Type: -

Identifier Source: secondary_id

200020

Identifier Type: -

Identifier Source: org_study_id