Bladder Cancer Clinical Trial

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

Summary

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

View Full Description

Full Description

Most bladder cancer patients (74%) present with NMIBC where the cancer is limited to the lining or support layer of the bladder. High-grade NMIBC is treated initially with endoscopic resection and intravesical immunotherapy, followed by bladder instillations of BCG. Most patients with high-risk, high-grade NMIBC are able to retain their bladders and avoid more invasive treatments. However, 24-61% of patients will have their cancers recur within 12 months of treatment with BCG (BCG failures), and they have limited treatment options. National guidelines recommend consideration between two alternatives: additional medical management and radical cystectomy (removal of the bladder). Selecting between these options involves weighing the risk of progression of bladder cancer and loss of a window of potential cure versus the risk of morbidity and loss of quality of life (QOL) with bladder removal. This complex decision-making engages patients and their caregivers, who may be impacted by the urinary, sexual, and bowel dysfunctions that can occur with NMIBC treatment.

The investigators will evaluate this research question on a large scale in real world practice settings including academic and community-based practices and examine patient-centered outcomes. The investigators have engaged stakeholders with diverse perspectives relevant to this research question, including patients, caregivers, national patient advocacy organizations, national medical specialty organizations, guideline developers, health care payers, and industry. By engaging broad expertise relevant to this research question, the investigators will ensure that the study results will help NMIBC patients whose cancer recurs after BCG treatment make more informed decisions that improve the health outcomes that are important to them.

CISTO is an observational study that will not affect the treatment that patients chose. Patient surveys will occur at study entry and at follow-up assessments for up to four years. There will also be a qualitative sub-study that will include interviews of approximately 50 patients and 25 caregivers recruited from the observational cohort study.

View Eligibility Criteria

Eligibility Criteria

Patient Eligibility, Inclusion Criteria:

Adult 18 years of age or older; and

Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:

Pathology documentation from any hospital/clinic/medical center, and
More than 50% urothelial carcinoma component in the specimen
History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and
In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.

Patient Eligibility, Exclusion Criteria:

Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
Previous history of cystectomy or radiation therapy for bladder cancer;
Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
Any history of upper tract urothelial carcinoma;
Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
Contraindication to radical cystectomy (e.g., ASA of 4);
Contraindication to medical therapy (i.e., intolerant of all medical therapies);
Unable to provide written informed consent in English;
Unable to be contacted for research surveys;
Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC or any blinded interventional trial for NMIBC.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

900

Study ID:

NCT03933826

Recruitment Status:

Recruiting

Sponsor:

University of Washington

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There are 38 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Annalia E. Mefford
Contact
[email protected]
Jeffrey Nix, MD
Principal Investigator
Mayo Clinic Cancer Center
Phoenix Arizona, 85054, United States More Info
Clinical Trials Office
Contact
855-776-0015
Mark Tyson, MD, MPH
Principal Investigator
USC/Norris Comprehensive CA Center
Los Angeles California, 90033, United States More Info
Ileana Aldana
Contact
[email protected]
Nohely Aldana
Contact
[email protected]
Sia Daneshmand, MD
Principal Investigator
UCLA
Los Angeles California, 90095, United States More Info
Kristen Williams, MA
Contact
310-794-2939
[email protected]
Sarah Connor, MPH
Contact
[email protected]
Karim Chamie, MD, MSPH
Principal Investigator
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Leila Andres
Contact
949-557-0290
[email protected]
Jeffrey Bassett, MD
Principal Investigator
University of Colorado Anschutz Medical Campus
Aurora Colorado, 80045, United States More Info
Diego Escobar-Garcia
Contact
[email protected]
Janet Kukreja, MD
Principal Investigator
University of Miami
Miami Florida, 33136, United States More Info
Contact
305-243-5393
Chad R Ritch, MD
Principal Investigator
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States More Info
Rebecca Alexander
Contact
[email protected]
Scott Gilbert, MD
Principal Investigator
Emory University
Atlanta Georgia, 30322, United States More Info
Nahar Imtiaz
Contact
[email protected]
Viraj Master, MD, PhD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Parth Modi, MD, MS
Contact
773-795-8513
[email protected]
Megan Mendez, MS
Contact
773-702-1835
[email protected]
Parth Modi, MD, MS
Principal Investigator
University of Iowa
Iowa City Iowa, 52242, United States More Info
Laura Jacobus
Contact
[email protected]
Francesca I Nugent, BA
Contact
319-467-5833
[email protected]
Kenneth Nepple, MD
Principal Investigator
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Jane Ledesma
Contact
[email protected]
Eugene Lee, MD
Principal Investigator
Tulane University
New Orleans Louisiana, 70118, United States More Info
Maggie Huang
Contact
504-988-5800
[email protected]
Erik Castle, MD
Principal Investigator
Louisiana State University
New Orleans Louisiana, 70803, United States More Info
Michele Seeman
Contact
[email protected]
Mary Beth Westerman, MD
Principal Investigator
Johns Hopkins University, School of Medicine
Baltimore Maryland, 21231, United States More Info
Sandy Moore-Cooper
Contact
410-955-0009
[email protected]
N. Biafra Okoronkwo
Contact
410-502-8346
[email protected]
Max Kates, MD
Principal Investigator
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States More Info
Wendy Paxton, CCRC
Contact
[email protected]
Barbara Kyei
Contact
[email protected]
Rian Dickstein, MD
Principal Investigator
Kaiser Robertson, MD
Sub-Investigator
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Nnamdi Onochie
Contact
617-525-8753
[email protected]
Matthew Mossanen, M.D.
Principal Investigator
Michigan Medicine Rogel Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Sharada Lanka, MPH
Contact
[email protected]
Steven Thelen-Perry, MS
Contact
[email protected]
Jeffrey S Montgomery, MD
Principal Investigator
Spectrum Health
Grand Rapids Michigan, 49503, United States More Info
Nate Shurlow
Contact
[email protected]
Brian Lane, MD, PhD
Principal Investigator
Comprehensive Urology -- A Division of Michigan Healthcare Professionals
Royal Oak Michigan, 48073, United States More Info
Usama Makani
Contact
248-336-1080
Tarek Sangrid, MD
Contact
248-336-1080
Albert Einstein College of Medicine
Bronx New York, 10461, United States More Info
Andrea Ascencio
Contact
[email protected]
Alex Sankin, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States More Info
Dana E Mueller, MPH
Contact
[email protected]
Angela B Smith, MD, MS
Principal Investigator
Matthew Nielsen, MD
Sub-Investigator
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Alicia Patrick, MA
Contact
980-442-2000
[email protected]
Stephen B Riggs
Contact
704-355-8686
[email protected]
Stephen B Riggs, MD
Principal Investigator
The Ohio State University
Columbus Ohio, 43210, United States More Info
Katie White
Contact
[email protected]
Kamal Pohar, MD
Principal Investigator
Stephenson Cancer Center
Oklahoma City Oklahoma, 73114, United States More Info
Riza R Fabero, Bachelors
Contact
405-271-8001
[email protected]
Sanjay Patel, MD
Principal Investigator
Asante Rogue Regional Medical Center
Medford Oregon, 97504, United States More Info
Elizabeth Collmann
Contact
541-789-5003
Liam Macleod, MD, MPH
Principal Investigator
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Kirstin Rabinowitz, MPH
Contact
[email protected]
Tullika Garg, MD, MPH
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Spencer A Bell, MD, MS
Contact
704-241-2185
[email protected]
David Y Chen, MD, FACS
Principal Investigator
Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19122, United States More Info
Hanna Stambakio, BS
Contact
[email protected]
George Lin
Contact
[email protected]
Thomas Guzzo, MD, MPH
Principal Investigator
Carolina Urologic Research Center, LLC
Myrtle Beach South Carolina, 29572, United States More Info
Jennifer Sutton
Contact
[email protected]
Neal Shore, MD
Principal Investigator
Urology Associates, P.C.
Nashville Tennessee, 37209, United States More Info
Joe Wallace
Contact
[email protected]
David Morris, MD
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Wendy Williams, BSN
Contact
[email protected]
Brianne Leidy, RN
Contact
[email protected]
Kristen Scarpato, MD MPH FACS
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Sonobia R Garrett
Contact
214-645-8482
[email protected]
Catherine Robinson
Contact
214-645-8103
[email protected]
Solomon Woldu, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Marisa Lozano
Contact
[email protected]
Ashish Kamat, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
Grace Ihsiu Todd, MSN, ANP-BC
Contact
[email protected]
Ahmed Elshabrawy
Contact
[email protected]
Ahmed Mansour, MD
Principal Investigator
Robert Svatek, MD
Sub-Investigator
University of Utah
Salt Lake City Utah, 84132, United States More Info
Elizabeth Lignell, BS, CCRA, CCRC
Contact
[email protected]
Stefyn Hall, BS, BA
Contact
[email protected]
Brock O'Neil, MD
Principal Investigator
University of Washington
Seattle Washington, 98195, United States More Info
Kristin Follmer
Contact
[email protected]
John L Gore, MD, MS, FACS
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

900

Study ID:

NCT03933826

Recruitment Status:

Recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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