En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
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|ClinicalTrials.gov Identifier: NCT04235764|
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : November 19, 2020
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.
To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.
People ages 18 and older who need to have their bladder removed at the NIH.
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.
|Condition or disease|
- 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.
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.
- Medical condition requiring surgical removal of the bladder
- Men and women, age >= 18 years
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using Modified Existing Surgical Resectoscope Device|
|Actual Study Start Date :||September 9, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2023|
1/ Cohort 1
Bladder Cancer Patients
- Assessment of resectoscope device modification on pathologic standards for the TURBT procedure [ Time Frame: Time of surgery/pathologic assessment (7-10 days) ]-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.
- Assessment for possible bladder perforation in bladder specimens [ Time Frame: Time of surgery/pathologic assessment (7-10 days) ]The rate of occurrence will be described/tabulated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235764
|Contact: Sonia E Bellfield, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Vladimir A Valera Romero, M.D.||National Cancer Institute (NCI)|