Evaluation of Cxbladder and Adjudication of Atypical Cytology and Equivocal Cystoscopy.
Adenocarcinoma
/ diagnosis
Aged
Aged, 80 and over
Biomarkers, Tumor
/ genetics
Clinical Trials as Topic
Cystoscopy
False Negative Reactions
Female
Gene Expression Profiling
Humans
Male
Middle Aged
Predictive Value of Tests
Retrospective Studies
Urinary Bladder
/ pathology
Urinary Bladder Neoplasms
/ diagnosis
Urine
/ cytology
Atypical cytology
Cxbladder
Cytology
Diagnosis
Equivocal cystoscopy
Urothelial carcinoma
Journal
European urology
ISSN: 1873-7560
Titre abrégé: Eur Urol
Pays: Switzerland
ID NLM: 7512719
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
24
08
2018
accepted:
24
04
2019
pubmed:
20
5
2019
medline:
4
11
2020
entrez:
20
5
2019
Statut:
ppublish
Résumé
Cxbladder diagnostic tests combine genomic information from urinary mRNA with phenotypic information to either rule out low-risk individuals or identify patients at a high risk of urothelial carcinoma (UC). To evaluate the performance of Cxbladder and urine cytology, and Cxbladder's adjudication of atypical cytology and equivocal cystoscopy. This is a retrospective analysis of pooled data from three prospective Cxbladder clinical trials and one real-world clinical study. Physicians were blinded to Cxbladder results, and Cxbladder providers were blinded to clinical results. This study analyzed diverse urology practices in the USA, Australia, and New Zealand. A total of 1784 consecutive, prospectively recruited patients with hematuria or previously diagnosed UC provided 852 samples with both local cytology and Cxbladder results; 153 had atypical cytologies and 14 had both atypical cytology and equivocal cystoscopy. Negative predictive value (NPV) and proportion of tumors missed for Cxbladder and local cytology, and evaluation of Cxbladder for adjudicating atypical cytology and equivocal cystoscopy. Cxbladder ruled out 35% of patients and NPV 97% (95% confidence interval [CI] 94-98%) compared with 93% (95% CI 91-94%) for cytology; Cxbladder missed 8.5% and cytology missed 63% of tumors. UC was diagnosed in 26/153 cases of atypical cytology (17%). Cxbladder correctly adjudicated all these patients including those with both atypical cytology and equivocal cystoscopy; these patients had a positive Cxbladder result and were diagnosed with UC by pathology. The incidence of patients with both atypical cytology and equivocal cystoscopy is low. Cxbladder correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy, and outperformed cytology for accurately identifying patients who do not have UC. Cxbladder accurately rules out patients who do not have cancer, and adjudicates cytology and cystoscopy with inconclusive results, minimizing the need for patients to undergo further unnecessary tests and procedures.
Sections du résumé
BACKGROUND
Cxbladder diagnostic tests combine genomic information from urinary mRNA with phenotypic information to either rule out low-risk individuals or identify patients at a high risk of urothelial carcinoma (UC).
OBJECTIVE
To evaluate the performance of Cxbladder and urine cytology, and Cxbladder's adjudication of atypical cytology and equivocal cystoscopy.
DESIGN, SETTING, AND PARTICIPANTS
This is a retrospective analysis of pooled data from three prospective Cxbladder clinical trials and one real-world clinical study. Physicians were blinded to Cxbladder results, and Cxbladder providers were blinded to clinical results. This study analyzed diverse urology practices in the USA, Australia, and New Zealand. A total of 1784 consecutive, prospectively recruited patients with hematuria or previously diagnosed UC provided 852 samples with both local cytology and Cxbladder results; 153 had atypical cytologies and 14 had both atypical cytology and equivocal cystoscopy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Negative predictive value (NPV) and proportion of tumors missed for Cxbladder and local cytology, and evaluation of Cxbladder for adjudicating atypical cytology and equivocal cystoscopy.
RESULTS AND LIMITATIONS
Cxbladder ruled out 35% of patients and NPV 97% (95% confidence interval [CI] 94-98%) compared with 93% (95% CI 91-94%) for cytology; Cxbladder missed 8.5% and cytology missed 63% of tumors. UC was diagnosed in 26/153 cases of atypical cytology (17%). Cxbladder correctly adjudicated all these patients including those with both atypical cytology and equivocal cystoscopy; these patients had a positive Cxbladder result and were diagnosed with UC by pathology. The incidence of patients with both atypical cytology and equivocal cystoscopy is low.
CONCLUSIONS
Cxbladder correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy, and outperformed cytology for accurately identifying patients who do not have UC.
PATIENT SUMMARY
Cxbladder accurately rules out patients who do not have cancer, and adjudicates cytology and cystoscopy with inconclusive results, minimizing the need for patients to undergo further unnecessary tests and procedures.
Identifiants
pubmed: 31103391
pii: S0302-2838(19)30351-3
doi: 10.1016/j.eururo.2019.04.035
pii:
doi:
Substances chimiques
Biomarkers, Tumor
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
238-243Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.