Replacing invasive cystoscopy with urine testing for non-muscle invasive bladder cancer surveillance

Active Project Grant Awarded Last action

Award ID
R37CA275916
Recipient
Awarding agency
Obligated
$2,128,641

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date 64% complete
Place of performance
White River Junction, Hartford, VT, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
There are ~800,000 bladder cancer survivors in the US, making IT the fifth most prevalent cancer. This study focuses on the largest group of patients with bladder cancer, the 79% with non-muscle invasive early-stage cancer. Per current guideline recommendations, these patients undergo transurethral endoscopic resection followed by surveillance cystoscopy every 3 to 6 months, making cystoscopy common with over a million procedures per year. Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra. IT can be quite uncomfortable as IT is performed in non-sedated patients. In spite of this burden on patients, high-quality data on the benefits of high-intensity surveillance cystoscopy are lacking. The experts writing the guidelines recognized the unclear benefit of high-intensity surveillance and specifically stated: "there is an urgent need for studies to determine if less stringent follow-up regimens can be employed without significantly affecting oncologic outcomes in these patients." replacing cystoscopy with less invasive urine testing is such a less stringent follow-up regimen. Preliminary data show that the urine tests xpert bladder cancer monitor (mrna-based) and bladder epicheck (DNA methylation test) may replace cystoscopy procedures, given their high sensitivities. However, with a specificity 0.76 and 0.84, up to one out of four tests may be false positive, so many patients still have to undergo cystoscopy for positive tests. Thus, longitudinal comparative data are needed before these tests can be considered for routine care. Specifically, we need evidence that programmatic surveillance with urine tests significantly decreases the burden of surveillance for patients and has acceptable oncologic outcomes in diverse populations of bladder cancer survivors. Here, we will define the extent to which patients' burden of surveillance can be reduced with bladder cancer urine tests. We propose a three-site randomized phase 2 trial including 240 patients with early-stage bladder cancer. After a normal surveillance cystoscopy at study entry, patients will be randomized 1:1:1 to programmatic surveillance with the xpert bladder cancer urine test, the bladder epicheck urine test, or standard cystoscopy. We will (1) determine whether burden of surveillance is significantly decreased in the urine testing arms versus standard cystoscopy, (2) compare short-term safety outcomes in the urine testing arms versus standard cystoscopy at 1 and 2 years, and (3) estimate important feasibility data for a subsequent large non-inferiority comparative effectiveness trial. In summary, we will systematically study whether the burden of surveillance cystoscopy can be improved among bladder cancer survivors by replacing invasive cystoscopy with urine testing, ultimately improving their quality of life. If bladder cancer urine tests significantly decrease the burden of surveillance, our data will provide a strong justification for a subsequent comparative effectiveness trial of programmatic surveillance with urine testing versus standard cystoscopy that is large enough to be powered for oncologic outcomes.

Transactions

Action Obligated Date
Amendment $645,926
Amendment $332,897
Amendment $565,926
Original award $583,892

Subawards

Subrecipient Amount Awarded
The Medical University Of South Carolina Change in Scope of Work in Year 3 Requiring Revised Budget: 1) no new enrollees; study activities limited to 11 projected follow-up visits (includes data… $19,474
Case Western Reserve University Team members will be responsible for conducting participant-related human subjects’ activities including, but not limited to, screening, recruiting, and… $91,953
The University Of Texas Southwestern Medical Center conduct participant related human subjects activities; screening, recruiting and enrolling, regulatory compliance. contribute to study conduct. $148,987
Vandeventer Place Research Foundation Team members will be responsible for conducting participant-related human subjects’ activities including, but not limited to, screening, recruiting, and… $40,374
Bay Pines Foundation, Inc. $36,978
Trustees Of Dartmouth College support data collection infrastructure. Provide the resources to develop all necessary data collection and randomization infrastructure. Oversee trial design… $46,817
Tampa VA Research And Education Foundation, Inc. conduct participant related human subjects activities; screening, recruiting and enrolling, regulatory compliance. contribute to study conduct. $35,553
Case Western Reserve University Team members will be responsible for conducting participant-related human subjects’ activities including, but not limited to, screening, recruiting, and… $45,977
The Medical University Of South Carolina Team members will be responsible for conducting participantrelated human subjects’ activities including, but not limited to, screening, recruiting, and… $87,769
Vandeventer Place Research Foundation Team members will be responsible for conducting participant-related human subjects’ activities including, but not limited to, screening, recruiting, and… $20,187
The University Of Texas Southwestern Medical Center conduct participant related human subjects activities; screening, recruiting and enrolling, regulatory compliance. contribute to study conduct. $148,987
Bay Pines Foundation, Inc. Team members will be responsible for conducting participant-related human subjects’ activities including, but not limited to, screening, recruiting, and… $17,950
The University Of Texas Southwestern Medical Center activities including, but not limited to, screening, recruiting, and enrolling participants, and conducting and monitoring accurate and complete data… $148,987
Trustees Of Dartmouth College support data collection infrastructure. Provide the resources to develop all necessary data collection and randomization infrastructure. Oversee trial design… $78,061
The University Of Texas Southwestern Medical Center conduct participant related human subjects activities; screening, recruiting and enrolling, regulatory compliance. contribute to study conduct. $148,987
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Quick answers

Who received award R37CA275916?

R37CA275916 was awarded to Veterans Education And Research Association Of Northern New England, Inc. by National Cancer Institute (National Institutes of Health) on August 1, 2023.

How much is award R37CA275916 worth?

$2,128,641 has been obligated on R37CA275916.

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