Women present with smaller tumors, and every modality found fewer of them
Female participants with HCC had an average largest lesion of 2.5 cm compared with 3.3 cm in men. Sensitivity was lower across all testing modalities.
Does hepatocellular carcinoma present differently in women, and does surveillance account for it?
In CLiMB, female participants with HCC had an average largest lesion of 2.5 cm compared with 3.3 cm in male participants. All testing modalities demonstrated lower sensitivity in women, which the publication attributes to the smaller lesion size in that group.
Cohort at a glance
| HCC-positive participants, male | 30 of 46, 65.2% |
|---|---|
| HCC-positive participants, female | 16 of 46, 34.8% |
| Average largest lesion, female | 2.5 cm |
| Average largest lesion, male | 3.3 cm |
| Sensitivity pattern | Lower for all testing modalities in female participants |
| HelioLiver Dx relative to other modalities | 0% to 36.7% higher sensitivity across sex, ethnicity, and race subgroups |
A difference in what the tumors looked like
Participants with HCC in CLiMB were twice as likely to be male, 65% compared with 35%, consistent with the known epidemiology of the disease. The publication also reports a difference in lesion size at detection between male and female participants.
Cohort
Of the 46 participants with confirmed HCC, 30 were male and 16 were female. The analysis below compares lesion size and detection performance between those two groups.
What the data showed
Female participants with HCC had an average largest lesion of 2.5 cm. Male participants averaged 3.3 cm. All testing modalities demonstrated lower sensitivity in female participants, which the publication attributes to the smaller lesion size in that group.
Across subgroup analyses by sex, ethnicity, and race, the HelioLiver Dx test demonstrated sensitivities that were 0% to 36.7% higher than the other testing modalities, with specificities 0.6% to 15.4% lower.
What it means at the point of care
Detecting HCC at an early stage allows for more treatment options, including curative treatment. In CLiMB, the other testing modalities had sensitivities of 0% to 4.8% for lesions 2 cm or smaller, compared with 28.6% for the HelioLiver Dx test.
This is the same finding as the small-lesion evidence case in this series, viewed through a different lens. The publication reports that ultrasound performance is influenced by patient characteristics, including lesion size, and that female participants in CLiMB had smaller HCC lesions on average.
Three things to carry forward
- Female CLiMB participants with HCC had an average largest lesion of 2.5 cm compared with 3.3 cm in male participants.
- All testing modalities detected fewer cancers in women, a difference the authors attribute to smaller lesion size.
- Across sex, ethnicity, and race subgroups, the HelioLiver Dx test demonstrated higher sensitivity than comparator modalities, with modestly lower specificity.
- 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
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.