Where surveillance actually happens: community practice
Eighty percent of CLiMB participants were enrolled at community-based centers, the same setting where documented ultrasound adherence falls to 8.8%.
Does evidence generated at academic liver centers describe what happens in community practice?
In CLiMB, roughly four in five participants were enrolled at community-based centers rather than academic ones, which the publication reports supports the generalizability of the results to real-world US patients with cirrhosis. Published data put documented ultrasound adherence at 8.8% among patients followed primarily at community centers.
Cohort at a glance
| Clinical sites | 42, across the United States |
|---|---|
| Enrolled at community-based centers | 80.1% of HCC-negative and 82.6% of HCC-positive participants |
| Documented ultrasound adherence, overall | Approximately 24% |
| Documented adherence, community-followed patients | 8.8% |
| Real-world adherence in over 80,000 insured US patients | Approximately 9% |
| Study-related adverse events | 2, both fainting or lightheadedness during the blood draw |
Low sensitivity and low adherence
The publication concludes that ultrasound sensitivity remains poor and that adherence to HCC surveillance with ultrasound is inadequate.
Cohort
CLiMB enrolled across 42 clinical sites in the United States, and the great majority of participants, roughly four in five, came from community-based centers rather than academic ones. The paper explicitly notes that the demographic and clinical characteristics of the cohort were similar to a large study of commercially insured patients with cirrhosis in the United States.
What the data showed
Two findings sit side by side here, and they belong together.
First, ultrasound performance. The publication reports that the large representation of participants enrolled at community-based centers with potentially variable sonographer experience, combined with standardized central ultrasound reading and the high prevalence of small HCC lesions in the cohort, may have contributed to the low observed ultrasound performance. On generalizability, it states that the cohort’s demographic and clinical characteristics support the generalizability of the results to real-world US patients with cirrhosis.
Second, adherence. Pooled meta-analysis data found that only about 24% of patients with cirrhosis received ultrasound surveillance every six to twelve months, and that figure dropped to 8.8% among patients followed primarily at community centers. A real-world study of over 80,000 commercially insured American patients with cirrhosis found that approximately 9% received ultrasound every six to twelve months.
What it means at the point of care
Patient-reported barriers to receiving abdominal ultrasound include scheduling difficulties and lack of transportation. The publication reports that fewer than 25% of high-risk patients adhere to testing recommendations, and that patients cite travel and scheduling difficulties among the barriers to undergoing biannual ultrasound. In CLiMB, the only study-related adverse events across the entire validation cohort were two participants who fainted or felt lightheaded during the blood draw.
The publication notes that such limitations of ultrasound can potentially be mitigated through the availability of an accurate and convenient blood-based test.
Three things to carry forward
- Four in five CLiMB participants were enrolled at community-based centers, which the publication reports supports the generalizability of the results to real-world US patients with cirrhosis.
- Documented ultrasound adherence among community-followed patients with cirrhosis is 8.8%, and roughly 9% in a real-world cohort of over 80,000 insured US patients.
- The publication states that the limitations of ultrasound can potentially be mitigated through the availability of an accurate and convenient blood-based test.
- Taggart DJ, Mahajan S, Gallant MA, et al. A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma. J Hepatol. 2026;1-9. doi:10.1016/j.jhep.2026.04.012
- Wolf E, Rich NE, Marrero JA, et al. Use of hepatocellular carcinoma surveillance in patients with cirrhosis: a systematic review and meta-analysis. Hepatology. 2021;73:713-725.
- Yeo YH, Hwang J, Jeong D, et al. Surveillance of patients with cirrhosis remains suboptimal in the United States. J Hepatol. 2021;75:856-864.
- Singal AG, Tiro JA, Murphy CC, et al. Patient-reported barriers are associated with receipt of hepatocellular carcinoma surveillance in a multicenter cohort of patients with cirrhosis. Clin Gastroenterol Hepatol. 2021;19:987-995.e981.
About the CLiMB trial
CLiMB was a cross-sectional, prospective, blinded, multicenter validation study conducted across 42 clinical sites in the United States, evaluating the HelioLiver Dx test against abdominal ultrasound for the detection of hepatocellular carcinoma in adults with cirrhosis. Multiphasic MRI served as the reference standard. The HelioLiver Dx test met prespecified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound.
Enrolled vs. evaluable. A total of 1,556 patients were enrolled in the prospective CLiMB study and assigned to the validation cohort, of whom 1,285 completed the initial visit. At the 6-month follow-up visit, 17 participants were lost to follow-up and were excluded from analysis. Only participants with valid results from the HelioLiver Dx test, ultrasound, and multiphasic MRI were considered evaluable. A total of 1,268 participants (81.5%) were evaluable, including 46 participants with HCC and 1,222 participants without HCC. Every performance figure in this series is calculated on that evaluable population. Published in the Journal of Hepatology, 2026. ClinicalTrials.gov identifier NCT03694600.
Have a case to contribute?
Clinicians using the HelioLiver Dx test can submit de-identified cases for consideration in this series.