Evidence map›Paper›PMID 33882992›Full record

ArticleClinical epigenetics2021

Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples.

Paolo Piatti, Yap Ching Chew, Michiko Suwoto, Taikun Yamada, Benjamin Jara, Xi-Yu Jia, Wei Guo, Saum Ghodoussipour, Siamak Daneshmand, Hamed Ahmadi and 6 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical epigenetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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.

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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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  20. Nanocomplexes of doxorubicin and DNA fragments for efficient and safe cancer chemotherapy.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
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

16 authors at 2 institutions in 1 country.

Paolo PiattiZymo Research Corp, Irvine, CA, USA.
Yap Ching ChewZymo Research Corp, Irvine, CA, USA.
Michiko SuwotoZymo Research Corp, Irvine, CA, USA.
Taikun YamadaZymo Research Corp, Irvine, CA, USA.
Benjamin JaraZymo Research Corp, Irvine, CA, USA.
Xi-Yu JiaZymo Research Corp, Irvine, CA, USA.
Wei GuoZymo Research Corp, Irvine, CA, USA.
Saum GhodoussipourDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Siamak DaneshmandDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Hamed AhmadiDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Jeffrey RiceZymo Research Corp, Irvine, CA, USA.
Jeffrey BhasinZymo Research Corp, Irvine, CA, USA.
Faith HollowayZymo Research Corp, Irvine, CA, USA.
Yvonne TsaiDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Yoshitomo ChiharaDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Gangning LiangDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. gliang@usc.edu.ORCID 0000-0001-8664-922X
University of Southern California · USWest Coast Solutions (United States) · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
Targeting DNA Methylation and the Cancer EpigenomeR35CA209859 · NCI · VAN ANDEL RESEARCH INSTITUTE · PI PETER A JONES · 2017 to 2026
$11.9M
NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

backgroundBladder cancer (BC) is the 5th most common cancer in the USA. Non-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome. However, recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance with cystoscopy. The invasiveness and high cost of cystoscopy poses significant burden on BC patients as well as on the healthcare system. In this study we test the feasibility of a simple, sensitive, and non-invasive detection of BC using Bladder CARE test in urine samples.

resultsUrine from 136 healthy and 77 BC subjects was collected using the at-home Bladder CARE Urine Collection Kit and analyzed with Bladder CARE test. The test measures the methylation level of three BC-specific biomarkers and two internal controls using methylation-sensitive restriction enzymes coupled with qPCR. Bladder CARE showed an overall sensitivity of 93.5%, a specificity of 92.6%, and a PPV and NPV of 87.8% and 96.2%, respectively. Bladder CARE has an LOD as low as 0.046%, which equates to detecting 1 cancer cell for every 2,200 cells analyzed. We also provided evidence that bisulfite-free methods to assess DNA methylation, like Bladder CARE, are advantageous compared to conventional methods that rely on bisulfite conversion of the DNA.

conclusionHighly sensitive detection of BC in urine samples is possible using Bladder CARE. The low LOD of the test and the measurement of epigenetic biomarkers make Bladder CARE a good candidate for the early detection of BC and possibly for the routine screening and surveillance of BC patients. Bladder CARE and the at-home urine sample collection system have the potential to (1) reduce unnecessary invasive testing for BC (2) reduce the burden of surveillance on patients and on the healthcare system, (3) improve the detection of early stage BC, and (4) allow physicians to streamline the monitoring of patients.

Indexed as

AdultAgedAged, 80 and overBiomarkers, TumorDNA MethylationEpigenesis, GeneticEpigenomicsFemaleHumansMaleMiddle AgedReproducibility of ResultsSensitivity and SpecificityUrinary Bladder NeoplasmsYoung AdultBiomarkers, TumorAt-home sample collectionBladder cancerDNA methylationNon-invasive testingUrine

Identifiers

PMID33882992
PMCPMC8059345
OpenAlexW3155611262

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.