Journal article
The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study
JMIR research protocols, Vol.12, e44264
05/31/2023
DOI: 10.2196/44264
PMCID: PMC10267778
PMID: 37256650
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 °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.
Details
- Title: Subtitle
- The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study
- Creators
- Yaqza Hussain - University Hospitals Coventry and Warwickshire NHS TrustAyman Bannaga - University Hospitals Coventry and Warwickshire NHS TrustNeil Fisher - Russells Hall HospitalAshwin Krishnamoorthy - University Hospitals Coventry and Warwickshire NHS TrustPeter Kimani - University of WarwickAhmad Malik - Fauji FertilizerMaria Truslove - University Hospitals Coventry and Warwickshire NHS TrustShivam Joshi - University Hospitals Coventry and Warwickshire NHS TrustMegan Hitchins - Cedars-Sinai Medical CenterAbdullah Abbasi - University of Iowa, Internal MedicineChristopher Corbett - New Cross HospitalMatthew Brookes - The Royal Wolverhampton NHS TrustHarpal Randeva - University Hospitals Coventry and Warwickshire NHS TrustNwe Ni Than - CoventryRamesh P Arasaradnam - University Hospitals Coventry & Warwickshire Warwick Medical School University of Warwick Leicester Cancer Research Centre University of Leicester
- Resource Type
- Journal article
- Publication Details
- JMIR research protocols, Vol.12, e44264
- DOI
- 10.2196/44264
- PMID
- 37256650
- PMCID
- PMC10267778
- NLM abbreviation
- JMIR Res Protoc
- ISSN
- 1929-0748
- eISSN
- 1929-0748
- Publisher
- JMIR Publications
- Language
- English
- Date published
- 05/31/2023
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984844345902771
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