Cargando…
The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study
BACKGROUND: Hepatocellular cancer (HCC) is associated with high mortality, and early diagnosis leads to better survival. Patients with cirrhosis, especially due to nonalcoholic fatty liver disease and viral hepatitis, are at higher risk of developing HCC and form the main screening group. The curren...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267778/ https://www.ncbi.nlm.nih.gov/pubmed/37256650 http://dx.doi.org/10.2196/44264 |
_version_ | 1785058997839069184 |
---|---|
author | Hussain, Yaqza Bannaga, Ayman Fisher, Neil Krishnamoorthy, Ashwin Kimani, Peter Malik, Ahmad Truslove, Maria Joshi, Shivam Hitchins, Megan Abbasi, Abdullah Corbett, Christopher Brookes, Matthew Randeva, Harpal Than, Nwe Ni Arasaradnam, Ramesh P |
author_facet | Hussain, Yaqza Bannaga, Ayman Fisher, Neil Krishnamoorthy, Ashwin Kimani, Peter Malik, Ahmad Truslove, Maria Joshi, Shivam Hitchins, Megan Abbasi, Abdullah Corbett, Christopher Brookes, Matthew Randeva, Harpal Than, Nwe Ni Arasaradnam, Ramesh P |
author_sort | Hussain, Yaqza |
collection | PubMed |
description | BACKGROUND: Hepatocellular cancer (HCC) is associated with high mortality, and early diagnosis leads to better survival. Patients with cirrhosis, especially due to nonalcoholic fatty liver disease and viral hepatitis, are at higher risk of developing HCC and form the main screening group. The current screening methods for HCC (6-monthly screening with serum alpha fetoprotein and ultrasound liver) have low sensitivity; hence, there is a need for better screening markers for HCC. OBJECTIVE: Our study, TENDENCY, aims to validate the novel screening markers (methylated septin 9, urinary volatile organic compounds, and urinary peptides) for HCC diagnosis and study these noninvasive biomarkers in liver disease. METHODS: This is a multicenter, nested case-control study, which involves comparing the plasma levels of methylated septin 9 between confirmed HCC cases and patients with cirrhosis (control group). It also includes the comparison of urine samples for the detection of HCC-specific volatile organic compounds and peptides. Based on the findings of a pilot study carried out at University Hospital Coventry & Warwickshire, we estimated our sample size to be 308 (n=88, 29% patients with HCC; n=220, 71% patients with cirrhosis). Urine and plasma samples will be collected from all participants and will be frozen at –80 °C until the end of recruitment. Gas chromatography–mass spectrometry will be used for urinary volatile organic compounds detection, and capillary electrophoresis–mass spectrometry will be used for urinary peptide identification. Real-time polymerase chain reaction will be used for the qualitative detection of plasma methylated septin 9. The study will be monitored by the Research and Development department at University Hospital Coventry & Warwickshire. RESULTS: The recruitment stage was completed in March 2023. The TENDENCY study is currently in the analysis stage, which is expected to finish by November 2023. CONCLUSIONS: There is lack of effective screening tests for hepatocellular cancer despite higher mortality rates. The application of more sensitive plasma and urinary biomarkers for hepatocellular cancer screening in clinical practice will allow us to detect the disease at earlier stages and hence, overall, improve HCC outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44264 |
format | Online Article Text |
id | pubmed-10267778 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-102677782023-06-15 The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study Hussain, Yaqza Bannaga, Ayman Fisher, Neil Krishnamoorthy, Ashwin Kimani, Peter Malik, Ahmad Truslove, Maria Joshi, Shivam Hitchins, Megan Abbasi, Abdullah Corbett, Christopher Brookes, Matthew Randeva, Harpal Than, Nwe Ni Arasaradnam, Ramesh P JMIR Res Protoc Protocol BACKGROUND: Hepatocellular cancer (HCC) is associated with high mortality, and early diagnosis leads to better survival. Patients with cirrhosis, especially due to nonalcoholic fatty liver disease and viral hepatitis, are at higher risk of developing HCC and form the main screening group. The current screening methods for HCC (6-monthly screening with serum alpha fetoprotein and ultrasound liver) have low sensitivity; hence, there is a need for better screening markers for HCC. OBJECTIVE: Our study, TENDENCY, aims to validate the novel screening markers (methylated septin 9, urinary volatile organic compounds, and urinary peptides) for HCC diagnosis and study these noninvasive biomarkers in liver disease. METHODS: This is a multicenter, nested case-control study, which involves comparing the plasma levels of methylated septin 9 between confirmed HCC cases and patients with cirrhosis (control group). It also includes the comparison of urine samples for the detection of HCC-specific volatile organic compounds and peptides. Based on the findings of a pilot study carried out at University Hospital Coventry & Warwickshire, we estimated our sample size to be 308 (n=88, 29% patients with HCC; n=220, 71% patients with cirrhosis). Urine and plasma samples will be collected from all participants and will be frozen at –80 °C until the end of recruitment. Gas chromatography–mass spectrometry will be used for urinary volatile organic compounds detection, and capillary electrophoresis–mass spectrometry will be used for urinary peptide identification. Real-time polymerase chain reaction will be used for the qualitative detection of plasma methylated septin 9. The study will be monitored by the Research and Development department at University Hospital Coventry & Warwickshire. RESULTS: The recruitment stage was completed in March 2023. The TENDENCY study is currently in the analysis stage, which is expected to finish by November 2023. CONCLUSIONS: There is lack of effective screening tests for hepatocellular cancer despite higher mortality rates. The application of more sensitive plasma and urinary biomarkers for hepatocellular cancer screening in clinical practice will allow us to detect the disease at earlier stages and hence, overall, improve HCC outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44264 JMIR Publications 2023-05-31 /pmc/articles/PMC10267778/ /pubmed/37256650 http://dx.doi.org/10.2196/44264 Text en ©Yaqza Hussain, Ayman Bannaga, Neil Fisher, Ashwin Krishnamoorthy, Peter Kimani, Ahmad Malik, Maria Truslove, Shivam Joshi, Megan Hitchins, Abdullah Abbasi, Christopher Corbett, Matthew Brookes, Harpal Randeva, Nwe Ni Than, Ramesh P Arasaradnam. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.05.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Hussain, Yaqza Bannaga, Ayman Fisher, Neil Krishnamoorthy, Ashwin Kimani, Peter Malik, Ahmad Truslove, Maria Joshi, Shivam Hitchins, Megan Abbasi, Abdullah Corbett, Christopher Brookes, Matthew Randeva, Harpal Than, Nwe Ni Arasaradnam, Ramesh P The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title | The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title_full | The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title_fullStr | The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title_full_unstemmed | The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title_short | The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study |
title_sort | fatty liver, cirrhosis, and liver cancer study (tendency): protocol for a multicenter case-control study |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267778/ https://www.ncbi.nlm.nih.gov/pubmed/37256650 http://dx.doi.org/10.2196/44264 |
work_keys_str_mv | AT hussainyaqza thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT bannagaayman thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT fisherneil thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT krishnamoorthyashwin thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT kimanipeter thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT malikahmad thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT truslovemaria thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT joshishivam thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT hitchinsmegan thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT abbasiabdullah thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT corbettchristopher thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT brookesmatthew thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT randevaharpal thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT thannweni thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT arasaradnamrameshp thefattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT hussainyaqza fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT bannagaayman fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT fisherneil fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT krishnamoorthyashwin fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT kimanipeter fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT malikahmad fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT truslovemaria fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT joshishivam fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT hitchinsmegan fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT abbasiabdullah fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT corbettchristopher fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT brookesmatthew fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT randevaharpal fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT thannweni fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy AT arasaradnamrameshp fattylivercirrhosisandlivercancerstudytendencyprotocolforamulticentercasecontrolstudy |