Cargando…
Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples
BACKGROUND: Bladder 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 w...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059345/ https://www.ncbi.nlm.nih.gov/pubmed/33882992 http://dx.doi.org/10.1186/s13148-021-01029-1 |
_version_ | 1783681180319612928 |
---|---|
author | Piatti, Paolo Chew, Yap Ching Suwoto, Michiko Yamada, Taikun Jara, Benjamin Jia, Xi-Yu Guo, Wei Ghodoussipour, Saum Daneshmand, Siamak Ahmadi, Hamed Rice, Jeffrey Bhasin, Jeffrey Holloway, Faith Tsai, Yvonne Chihara, Yoshitomo Liang, Gangning |
author_facet | Piatti, Paolo Chew, Yap Ching Suwoto, Michiko Yamada, Taikun Jara, Benjamin Jia, Xi-Yu Guo, Wei Ghodoussipour, Saum Daneshmand, Siamak Ahmadi, Hamed Rice, Jeffrey Bhasin, Jeffrey Holloway, Faith Tsai, Yvonne Chihara, Yoshitomo Liang, Gangning |
author_sort | Piatti, Paolo |
collection | PubMed |
description | BACKGROUND: Bladder 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. RESULTS: Urine 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. CONCLUSION: Highly 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13148-021-01029-1. |
format | Online Article Text |
id | pubmed-8059345 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80593452021-04-22 Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples Piatti, Paolo Chew, Yap Ching Suwoto, Michiko Yamada, Taikun Jara, Benjamin Jia, Xi-Yu Guo, Wei Ghodoussipour, Saum Daneshmand, Siamak Ahmadi, Hamed Rice, Jeffrey Bhasin, Jeffrey Holloway, Faith Tsai, Yvonne Chihara, Yoshitomo Liang, Gangning Clin Epigenetics Research BACKGROUND: Bladder 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. RESULTS: Urine 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. CONCLUSION: Highly 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13148-021-01029-1. BioMed Central 2021-04-21 /pmc/articles/PMC8059345/ /pubmed/33882992 http://dx.doi.org/10.1186/s13148-021-01029-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Piatti, Paolo Chew, Yap Ching Suwoto, Michiko Yamada, Taikun Jara, Benjamin Jia, Xi-Yu Guo, Wei Ghodoussipour, Saum Daneshmand, Siamak Ahmadi, Hamed Rice, Jeffrey Bhasin, Jeffrey Holloway, Faith Tsai, Yvonne Chihara, Yoshitomo Liang, Gangning Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title | Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title_full | Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title_fullStr | Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title_full_unstemmed | Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title_short | Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples |
title_sort | clinical evaluation of bladder care, a new epigenetic test for bladder cancer detection in urine samples |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059345/ https://www.ncbi.nlm.nih.gov/pubmed/33882992 http://dx.doi.org/10.1186/s13148-021-01029-1 |
work_keys_str_mv | AT piattipaolo clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT chewyapching clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT suwotomichiko clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT yamadataikun clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT jarabenjamin clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT jiaxiyu clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT guowei clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT ghodoussipoursaum clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT daneshmandsiamak clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT ahmadihamed clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT ricejeffrey clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT bhasinjeffrey clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT hollowayfaith clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT tsaiyvonne clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT chiharayoshitomo clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples AT lianggangning clinicalevaluationofbladdercareanewepigenetictestforbladdercancerdetectioninurinesamples |