Background: Salivary orosomucoid 1 (ORM1) is highly increased in hepatocellular carcinoma related to hepatitis B. Thus, this study aims to investigate the role of salivary ORM1 as an early diagnostic and prognostic biomarker of HCC related to hepatitis B. Methods: The sources included were original articles published from 2013 until 2023 (last date searched, January 2023) from ProQuest, Google Scholar, Springer, and ScienceDirect. The inclusion criteria were original research articles (observational cohort or diagnostic studies). Other article reviews, meta-analyses, non-comparative research, and in silico, in vitro and in vivo studies, technical reports, editor responses, conference abstracts, non-English, non-full-text, and irrelevant articles that were not related to either salivary ORM1, or hepatocellular carcinoma, hepatitis B, or kidney failure were excluded. Then, the ROBINS-I took was used to assess bias . The result was constructed with PICOS criteria within the table created in the google spreadsheet. This systematic review followed the PRISMA guidelines. Results: We included five diagnostic studies with 533 samples conducted in China and Japan. Even though limited original studies with homogenous PICO was a limitation, the evidence output of this study can still be well presented. Salivary ORM1 may be useful to detect early cancer diagnosis as rapidly increased levels of ORM1 can be observed in the early stages of HCC (four times higher than usual) and the biomarker has a sensitivity of 81.67% and a specificity of 77.5%. This biomarker is also able to detect the prognosis of individuals with the disease with or without chemotherapy because the higher the level of ORM1, the more liver damage occurs that leads to a poorer prognosis. Conclusions: Salivary ORM1 is a potential early diagnostic biomarker of HCC related to hepatitis B and a biomarker of the disease prognosis. Registration: Open Science Framework (OSF) (March 16, 2023).

Background: Salivary orosomucoid 1 (ORM1) is highly increased in hepatocellular carcinoma related to hepatitis B. Thus, this systematic review aimed to investigate the diagnostic and prognostic value of salivary orosomucoid 1 (ORM1) in patients with that mentioned disease. Methods: The sources included were original articles published from 2013 until 2023 (last date searched, January 2023) from 4 databases (ProQuest, Google Scholar, Springer, and ScienceDirect). The inclusion criteria were original research articles (observational cohort or diagnostic studies). Other article reviews, meta-analyses, non-comparative research, and in silico, in vitro and in vivo studies, technical reports, editor responses, conference abstracts, non-English, non-full-text, and irrelevant articles that were not related to either salivary ORM1, or hepatocellular carcinoma, hepatitis B, or kidney failure were excluded. Then, the ROBINS-I taken was used to assess bias. The result was constructed with PICOS criteria within the table created in the Google spreadsheet. This systematic review followed the PRISMA guidelines. Results: Five diagnostic studies with 533 samples conducted in China and Japan. Limited original studies with homogenous PICO were a limitation, but the evidence output of this study can still be well presented. Salivary ORM1 may be useful to detect early cancer diagnosis as rapidly increased levels of ORM1 can be observed in the early stages of HCC (four times higher than usual) and the biomarker has a sensitivity of 81.67% and a specificity of 77.5%. This biomarker can detect the prognosis of individuals with the disease with or without chemotherapy. It is because level of salivary ORM1 related to liver damage, the higher the level of ORM1, the more liver damage occurs which leads to a poorer prognosis. Conclusions: Salivary ORM1 is a potential early diagnostic biomarker of HCC related to hepatitis B and a biomarker of the disease prognosis. Registration: Open Science Framework (OSF) (March 16, 2023).