Evidence map›Paper›PMID 41042706›Full record

ArticleThe Journal of urology2026

Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma.

Kazutoshi Fujita, Makito Miyake, Mamoru Hashimoto, Takuto Shimizu, Jennifer Linehan, Joshua Gottlieb, Ian Pagano, Sergei Tikhonenkov, Michael Luu, Sunao Tanaka and 6 more

Abstract readMulticenter Study
In one paragraph

Article in The Journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Kazutoshi FujitaDepartment of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
Makito MiyakeDepartment of Urology, Nara Medical University, Nara, Japan.
Mamoru HashimotoDepartment of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
Takuto ShimizuDepartment of Urology, Nara Medical University, Nara, Japan.
Jennifer LinehanSaint John's Cancer Institute, Santa Monica, California.
Joshua GottliebSaint John's Cancer Institute, Santa Monica, California.
Ian PaganoCancer Prevention and Control Program, University of Hawaii Cancer Center, Honolulu, Hawaii.
Sergei TikhonenkovTranslational and Clinical Program, University of Hawaii Cancer Center, Honolulu, Hawaii.
Michael LuuSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Sunao TanakaSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Fernando SiguenciaSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Kaoru MurakamiSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Riko LeeSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Toru SakataniSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Charles J RosserSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Hideki FuruyaSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0002-9536-8662

Funding

University of Hawaii Cancer Center CCSGP30CA071789 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI Pallav Pokhrel · 1996 to 2026
$56.2M
The stromal microenvironment as a co-organizer of bladder carcinogenesis and progressionU54CA274375 · NCI · METHODIST HOSPITAL RESEARCH INSTITUTE · PI Keith Syson Chan · 2022 to 2026
$10.2M
VALIDATION OF A MULTIPLEXED ASSAY FOR BLADDER CANCER DIAGNOSISR01CA198887 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI ROSSER, CHARLES J · 2016 to 2025
$6.8M
A Multiplex Protein Biomarker-Based Immunoassay for the Early Detection of Bladder Cancer and its Implications in Tumor BiologyR01CA277810 · NCI · CEDARS-SINAI MEDICAL CENTER · PI Hideki Furuya, Charles J Rosser · 2023 to 2026
$1.6M
APPLICATION OF A MULTIPLEXED IMMUNOASSAY FOR THE DETECTION OF BLADDER CANCERUH3CA271377 · NCI · CEDARS-SINAI MEDICAL CENTER · PI ROSSER, CHARLES J · 2022 to 2024
$1.2M
NCI NIH HHS P30 CA071789NCI NIH HHS R01 CA198887NCI NIH HHS R01 CA277810NCI NIH HHS U54 CA274375NCI NIH HHS UH3 CA271377
6 · The paper itself

Abstract

purposeUrine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC) because of insufficient accuracy. This study evaluated a multiplex urine assay designed to accurately and noninvasively diagnose UTUC. MATERIALS AND

methodsOncuria-Detect is a multiplex immunoassay capable of detecting urothelial cancer using a single voided urine specimen. In the current multi-institutional study, we tested the assay's utility in identifying UTUC in 60 subjects presenting for evaluation of upper tract mass compared with samples from 60 age-, sex-, and race-matched controls. Cancer status was confirmed by histopathological assessment of tissue specimens obtained during ureteroscopy/biopsy or at the time of definitive surgical intervention (nephroureterectomy or ureterectomy).

resultsFor detecting UTUC, Oncuria-Detect provided an AUC of 0.77 (95% CI: 0.70-0.84) with an overall sensitivity of 93%, specificity of 55%, negative predictive value 89%, and positive predictive value 67%. Assay sensitivity values for low-grade, high-grade, noninvasive, and invasive UTUC were 94%, 93%, 93%, and 92%, respectively. Voided urine cytology showed an overall sensitivity of 54%, specificity of 100%, negative predictive value 31.0%, and positive predictive value 100%. Selective (upper tract) cytology had a sensitivity of 80%. Oncuria-Detect outperformed both noninvasive voided urinary cytology and invasive selective cytology in overall assay performance.

conclusionsOncuria-Detect accurately identified and categorized UTUC and discriminated patients with cancer from nontumor-bearing individuals. The Oncuria-Detect test provides a rapid, accurate, and noninvasive method for detecting UTUC.

Indexed as

Biomarkers, TumorCarcinoma, Transitional CellKidney NeoplasmsUreteral NeoplasmsAgedAged, 80 and overFemaleHumansImmunoassayMaleMiddle AgedPredictive Value of TestsSensitivity and SpecificityBiomarkers, Tumorbiomarkersdiagnosismultiplex protein assayupper tract urothelial carcinomaurinalysis

Identifiers

PMID41042706
PMCPMC12794688

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.