San Diego Cirrhosis Registry Study

About

The San Diego Cirrhosis Registry study includes subjects with any etiology of cirrhosis including, but not limited to: MASH, Alcoholic Liver Disease (ALD), Hepatitis B virus (HBV), Hepatitis C virus (HCV), autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), alpha-1-antitryspin deficiency and cryptogenic cirrhosis. Patients with cirrhosis due to Wilson disease and iron overload may also be included. Cirrhosis patients with or without HIV infection may also be included.

A cirrhotic liver is unable to perform its normal functions and is at risk for failure. Patients with cirrhosis may have symptoms such as fluid accumulation in the belly, confusion, yellowing of the skin, or bleeding from the esophagus. When the liver fails, the only known effective treatment is liver transplantation.

We are trying to find out more about patients with cirrhosis or those having high suspicion of cirrhosis in the Greater San Diego area. The purpose of this study is to investigate the natural history of cirrhosis and develop noninvasive methods and approaches for its accurate assessment.

There will be approximately 500 participants enrolled at UCSD. The visits will be conducted primarily at University of California San Diego locations either at Altman Clinical Research Institute, Perlman Clinic, or MASLD Research Center on Executive Drive in La Jolla, CA.

Study Design

There will be a primary baseline visit and additional follow-up visits. Each follow-up visit will have a time window around the target date for the visit; the time window is an interval of 12 months during which the study visit may be completed, and the data collected at the visit may be used to fulfill the data collection requirements for the visit. Each visit has an ideal date for the visit, a lower window date (opening date for the window) and an upper window date (closing date for the window). The dates for a specific participant will be specified on the visit time windows sheet for the participant. 

Standardized methods will be used to collect all data and samples to better ensure consistency and protocol compliance. The manner by which data will be collected is as follows:

•  Participants will be instructed to attend these visit after a 12 hour fast and will be provided either a snack or voucher to be used at the hospital cafeteria.
•  For each subject, the study visit will be for approximately 2-3 hours.

Specific Aims

Primary Aims

1. To create a longitudinal cohort to investigate non-invasive imaging biomarkers to predict disease progression and clinical outcomes of cirrhosis. 
2. To create a longitudinal cohort to investigate whether changes in non-invasive imaging biomarkers predict disease progression and clinical outcomes in cirrhosis.
3. To define clinically significant changes in non-invasive imaging biomarkers and compare the diagnostic accuracy of magnetic resonance and ultrasound-based modalities.
4. To create a specimen bank [serum, plasma, urine, whole blood/ Deoxyribonucleic acid (DNA), Peripheral blood mononuclear cells (PBMCs), stool and liver tissue, if available] suitable for development of prognostic non-imaging biomarkers.

Recent Publications

1. Tamaki N, Kimura T, Wakabayashi SI, Umemura T, Izumi N, Loomba R, Kurosaki M. Cardiometabolic criteria as predictors and treatment targets of liver-related events and cardiovascular events in metabolic dysfunction-associated steatotic liver disease. Aliment Pharmacol Ther. 2024 Aug 8. doi: 10.1111/apt.18205. Epub ahead of print. PMID: 39115116. PubMed
2. Bridi L, Agrawal S, Tesfai K, Madamba E, Bettencourt R, Richards LM, Khera AV, Loomba R, Ajmera V. The impact of genetic risk on the prevalence of advanced fibrosis and cirrhosis in prospectively assessed patients with type 2 diabetes. Aliment Pharmacol Ther. 2024 Aug;60(3):369-377. doi: 10.1111/apt.18099. Epub 2024 Jun 2. PMID: 38825972; PMCID: PMC11236495. PubMed
3. Tamaki N, Kimura T, Wakabayashi SI, Umemura T, Izumi N, Loomba R, Kurosaki M. Editorial: Has MetALD met the presumption? Authors' reply. Aliment Pharmacol Ther. 2024 Jul;60(1):99-100. doi: 10.1111/apt.18047. Epub 2024 May 17. PMID: 38757828. PubMed
4. Tamaki N, Kimura T, Wakabayashi SI, Umemura T, Kurosaki M, Loomba R, Izumi N. Long-term clinical outcomes in steatotic liver disease and incidence of liver-related events, cardiovascular events and all-cause mortality. Aliment Pharmacol Ther. 2024 Jul;60(1):61-69. doi: 10.1111/apt.18015. Epub 2024 Apr 25. PMID: 38664876. PubMed
5. Noureddin N, Huang DQ, Bettencourt R, Siddiqi H, Majzoub AM, Nayfeh T, Tamaki N, Izumi N, Nakajima A, Idilman R, Gumussoy M, Oz DK, Erden A, Gidener T, Allen AM, Ajmera V, Loomba R. Natural history of clinical outcomes and hepatic decompensation in metabolic dysfunction-associated steatotic liver disease. Aliment Pharmacol Ther. 2024 Jun;59(12):1521-1526. doi: 10.1111/apt.17981. Epub 2024 Apr 3. PMID: 38571305. PubMed
6. Siddiqi H, Huang DQ, Mittal N, Nourredin N, Bettencourt R, Madamba E, Amangurbanova M, Hernandez C, Sirlin C, Yin M, Loomba R. Repeatability of vibration-controlled transient elastography versus magnetic resonance elastography in patients with cirrhosis: A prospective study. Aliment Pharmacol Ther. 2024 Aug;60(4):484-491. doi: 10.1111/apt.18118. Epub 2024 Jun 11. PMID: 38863232. PubMed
7. Gawrieh S, Vilar-Gomez E, Woreta TA, Lake JE, Wilson LA, Price JC, Naggie S, Sterling RK, Heath S, Corey KE, Cachay ER, Ajmera V, Tonascia J, Sulkowski MS, Chalasani N, Loomba R. Prevalence of steatotic liver disease, MASLD, MetALD and significant fibrosis in people with HIV in the United States. Aliment Pharmacol Ther. 2024 Mar;59(5):666-679. doi: 10.1111/apt.17849. Epub 2023 Dec 29. PMID: 38158589; PMCID: PMC10922859. PubMed

Funding

This study is supported by the John C. Martin Research Foundation. For more information, please visit https://thejcmfoundation.org/

For additional questions regarding this study please contact:

Phone: (858) 246-2179

masld@health.ucsd.edu