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JMIR Res Protoc

Title:		"The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study"
Author(s):		Hussain Y; Bannaga A; Fisher N; Krishnamoorthy A; Kimani P; Malik A; Truslove M; Joshi S; Hitchins M; Abbasi A; Corbett C; Brookes M; Randeva H; Than NN; Arasaradnam RP;
Address:		"University Hospitals Coventry & Warwickshire, Coventry, United Kingdom. Russells Hall Hospital, Dudley, United Kingdom. Warwick Medical School, University of Warwick, Warwick, United Kingdom. Pakistan Kidney and Liver institute and Research Center, Lahore, Pakistan. Cedars-Sinai Medical Center, Los Angeles, CA, United States. New Cross Hospital, Wolverhampton, United Kingdom. Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom"
Journal Title:		JMIR Res Protoc
Year:		2023
Volume:		20230531
Issue:
Page Number:		e44264 -
DOI:		10.2196/44264
ISSN/ISBN:		1929-0748 (Print) 1929-0748 (Electronic) 1929-0748 (Linking)
Abstract:		"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 degrees 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"
Keywords:		cirrhosis fatty liver fatty liver disease hepatitis hepatocellular cancer liver cancer methylated septin 9 urinary peptides urinary volatile organic compounds;
Notes:		"PubMed-not-MEDLINEHussain, 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 eng Canada 2023/05/31 JMIR Res Protoc. 2023 May 31; 12:e44264. doi: 10.2196/44264"