SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using Modified Existing Surgical Resectoscope Device

Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using Modified Existing Surgical Resectoscope Device


  • Org Study ID: 200020
  • Secondary ID: 20-C-0020
  • NCT ID: NCT04235764
  • NCT Alias:
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: National Institutes of Health Clinical Center (CC)

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.

Overal Status Start Date Phase Study Type
Recruiting September 30, 2020 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Assessment of resectoscope device modification on pathologic standards for the TURBT procedure

Primary Outcome 1 - Time Frame: Time of surgery/pathologic assessment (7-10 days)

Condition:

  • Bladder Cancer

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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Vladimir A Valera Romero, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: Sonia E Bellfield, R.N.

Phone: (240) 760-6118

Email: sonia.bellfield@nih.gov

Link: NIH Clinical Center Detailed Web Page

Location

Facility Status Contact
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United States
Recruiting For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937