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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04235764.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorVladimir A Valera Romero
