Evidence map›Paper›PMID 37980511›Full record

ArticleBMC cancer2023

Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer.

John L Gore, Erika M Wolff, Bryan A Comstock, Kristin M Follmer, Michael G Nash, Anirban Basu, Stephanie Chisolm, Douglas B MacLean, Jenney R Lee, Yair Lotan and 7 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03933826 (CISTO), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03933826 active not recruitingnot on this map

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

TypeobservationalSponsorUniversity of WashingtonRan2019 to 2029Enrolled570ConditionsBladder Cancer, Cancer of the Bladder, Recurrent, Non-muscle Invasive Bladder Cancer
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 1 country.

John L GoreDepartment of Urology, University of Washington, Seattle, WA, USA. jlgore@uw.edu.
Erika M WolffDepartment of Urology, University of Washington, Seattle, WA, USA.
Bryan A ComstockDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Kristin M FollmerDepartment of Urology, University of Washington, Seattle, WA, USA.
Michael G NashDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Anirban BasuDepartments of Pharmacy, Health Services, and Economics, University of Washington, Seattle, WA, USA.
Stephanie ChisolmBladder Cancer Advocacy Network, Bethesda, MD, USA.
Douglas B MacLeanCISTO Advocate Advisory Board, Carnation, WA, USA.
Jenney R LeeDepartment of Urology, University of Washington, Seattle, WA, USA.
Yair LotanDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Sima P PortenDepartment of Urology, UCSF School of Medicine, San Francisco, CA, USA.
Gary D SteinbergDepartment of Urology, Rush University Medical Center, Chicago, IL, USA.
Sam S ChangDepartment of Urology, Vanderbilt University Medical Center, Nashville, TN, USA.
Scott M GilbertDepartment of Genitourinary Oncology, H. Lee Moffit Cancer Center and Research Institute, Tampa, FL, USA.
Larry G KesslerDepartment of Health Systems and Population Health, School of Public Health, University of Washington, Seattle, WA, USA.
Angela B SmithDepartment of Urology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
CISTO Collaborative
University of Washington · USBladder Cancer Advocacy Network · USAdvisory Board Company (United States) · USMoffitt Cancer Center · USRush University Medical Center · USThe University of Texas Southwestern Medical Center · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · USVanderbilt University Medical Center · US

Funding

Patient-Centered Outcomes Research Institute PCS-2017C3-9380
6 · The paper itself

Abstract

backgroundBladder cancer poses a significant public health burden, with high recurrence and progression rates in patients with non-muscle-invasive bladder cancer (NMIBC). Current treatment options include bladder-sparing therapies (BST) and radical cystectomy, both with associated risks and benefits. However, evidence supporting optimal management decisions for patients with recurrent high-grade NMIBC remains limited, leading to uncertainty for patients and clinicians. The CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options) Study aims to address this critical knowledge gap by comparing outcomes between patients undergoing BST and radical cystectomy.

methodsThe CISTO Study is a pragmatic, prospective observational cohort trial across 36 academic and community urology practices in the US. The study will enroll 572 patients with a diagnosis of recurrent high-grade NMIBC who select management with either BST or radical cystectomy. The primary outcome is health-related quality of life (QOL) at 12 months as measured with the EORTC-QLQ-C30. Secondary outcomes include bladder cancer-specific QOL, progression-free survival, cancer-specific survival, and financial toxicity. The study will also assess patient preferences for treatment outcomes. Statistical analyses will employ targeted maximum likelihood estimation (TMLE) to address treatment selection bias and confounding by indication. DISCUSSION: The CISTO Study is powered to detect clinically important differences in QOL and cancer-specific survival between the two treatment approaches. By including a diverse patient population, the study also aims to assess outcomes across the following patient characteristics: age, gender, race, burden of comorbid health conditions, cancer severity, caregiver status, social determinants of health, and rurality. Treatment outcomes may also vary by patient preferences, health literacy, and baseline QOL. The CISTO Study will fill a crucial evidence gap in the management of recurrent high-grade NMIBC, providing evidence-based guidance for patients and clinicians in choosing between BST and radical cystectomy. The CISTO study will provide an evidence-based approach to identifying the right treatment for the right patient at the right time in the challenging clinical setting of recurrent high-grade NMIBC.

trial registrationClinicalTrials.gov, NCT03933826. Registered on May 1, 2019.

Indexed as

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdministration, IntravesicalBCG VaccineCystectomyHumansMulticenter Studies as TopicNeoplasm InvasivenessNeoplasm Recurrence, LocalObservational Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesQuality of LifeAdjuvants, ImmunologicBCG VaccineAdministration, intravesicalNon-muscle invasive bladder cancerObservational studyPatient-centered carePragmatic trialQuality of lifeRadical cystectomy

Identifiers

PMID37980511
PMCPMC10657633
OpenAlexW4388791693

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.