Biomarker – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ Fri, 05 Apr 2024 04:38:37 +0000 en-AU hourly 1 https://wordpress.org/?v=6.6.2 https://i0.wp.com/clinicalvalue.com/wp-content/uploads/2023/01/apple-touch-icon.png?fit=32%2C32&ssl=1 Biomarker – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ 32 32 225041835 Looking to the Future – Blood-based Biomarkers for Liver Cancer Surveillance https://clinicalvalue.com/en-au/looking-to-the-future-blood-based-biomarkers-for-liver-cancer-surveillance/ Mon, 26 Feb 2024 14:04:01 +0000 https://clinicalvalue.com/?p=8072 ...

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Alpha-fetoprotein (AFP) is a blood-based biomarker that’s used together with ultrasound to detect liver cancer, but it’s by no means a perfect test. Experts are hopeful that emerging, specific blood-based biomarkers will prove useful in liver cancer surveillance — potentially as stand-alone tests.

What are some of the barriers to ultrasound surveillance?

For patients, some of the problems with ultrasound-based liver cancer surveillance include access to a clinic with an ultrasound machine, travel times and costs, as well as the inconvenience of attending appointments (1, 2). For clinicians, there may be differences in how the ultrasound is reported between sonographers (inter-observer variability) (1, 2).

What are the advantages of specific blood-based biomarkers over ultrasound alone?

Blood-based biomarker surveillance only requires a simple blood test. The risk of liver cancer is assessed using clinical scores, removing the need for ultrasound altogether (1, 2). Biomarker based surveillance may make it easier for patients to participate in liver cancer surveillance (1).

So, what blood-based biomarkers are currently used for liver cancer surveillance?

AFP is a blood-based biomarker currently used in hepatocellular carcinoma (HCC) surveillance in Australia (1). AFP tests are subsidised through the Medicare Benefits Schedule (MBS) for detecting and monitoring hepatic tumours (3). However, AFP use has been limited by its low sensitivity and suboptimal specificity (3).

While AFP is not used as a stand-alone surveillance test, it can help improve the detection of early-stage HCC when used together with ultrasound (1, 2).

What emerging biomarkers may be used for surveillance in the future?

There are two biomarkers showing promise for HCC surveillance, both of which are highly specific for the diagnosis of HCC (1):

  • lens culinaris agglutinin-reactive fraction of AFP (alpha-fetoprotein L3 or AFP-L3); and
  • des-gamma-carboxy prothrombin (DCP) (1).

Levels of these biomarkers are assessed using a simple blood test. The results of this blood test are used along with patient information to assess the risk of HCC. Two methods have been developed to calculate a clinical score, these are called GALAD and GAAD (1).

Both of these scores are still undergoing evaluation to check they have sufficient sensitivity and specificity (2). They are yet to be incorporated into clinical guidelines, or be subsidised by the MBS (3). If validated, the future use of non-invasive biomarkers for liver cancer surveillance holds promise, as it may allow for point-of-care testing with objective results (2).

GALAD

A serum biomarker-based model called GALAD can be used to predict the probability of HCC
in people with chronic liver disease (cirrhosis or chronic hepatitis B) (3).

The GALAD score is made up of (3):

G – gender (sex)
A – age
L – alpha-fetoprotein L3 (AFP-L3)
A – AFP
D – DCP

GAAD

Another clinical score using biomarkers is the GAAD score.

The GAAD clinical score is made up of (1):

G – gender (sex)
A – age
A – AFP
D – DCP

Further information

For a more in-depth discussion of blood-based biomarkers in HCC surveillance, see the Research Review Educational Series: Hepatocellular carcinoma surveillance and the emerging role of biomarker-based models (2023).

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Building modern hepatocellular carcinoma surveillance programmes: taking steps to address a leading cause of liver cancer death in Asia https://clinicalvalue.com/en-au/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ Wed, 23 Aug 2023 02:51:53 +0000 https://clinicalvalue.com/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program....

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Quick Summary

HCC is a leading cause of cancer mortality in Asia. Causes of HCC include viral hepatitis B and C infections, with recent increases in metabolic disorders, such as NAFLD, also playing a factor.

Early HCC interventions are highly effective and can lead to improved patient outcomes and survival. Therefore, HCC surveillance programs are pivotal in detecting HCC early and making the appropriate interventions.

In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs in Asia, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program:

  1. Include HCC surveillance in national program and strategic plans
    HCC surveillance programs should be fit into the national health strategy where appropriate, taking into account the local incidence and prevelance rates, and existing priorities and resources.
  2. Secure sustainable funding commitments
    Long-term resourcing and financing is key to making HCC survaillance programs successful. The current health financign system in the area, and ability to pay should be assessed, while exploring various funding methods such as centralised healthcare coverage or private insurance.
  3. Collect, analyse, and utilise data to inform program design
    The development of HCC surveillance program should be based on data, such as HCC epidemiology, patient outcomes, human and economic cost of HCC. These data should be collected and analysed.
  4. Adopt optimal technologies to advance HCC surveillance
    Technology can help to improve access to HCC surveillance programs, as well as improve patient outcomes by detecting HCC early. Some examples include: including additional biomarkers such as PIVKA-II, using biomarker based digital algorithms and diagnostic models, using more advanced imaging techniques, and adapting IT systems to support surveillance programs.
  5. Mobilise existing resources for HCC surveillance
    Tapping on exisiting resources to expand capacity for HCC care and surveillance., For example increasing the range of HCPs who can diagnose and manage HCC like primary and community HCPs, expanding private healthcare capacity in HCC care.
  6. Engage a broad spectrum of stakeholders to further surveillance goals
    Governmental decision-makers, physicians, patients and PAGs, payers and industry need to come together to drive implementation of a robust HCC surveillance programs that address needs of all stakeholders.
  7. Raise awareness and provide education on the need for HCC suveillance
    Raising the knowledge among the general population and HCPs on HCC and the importance of surveillance can improve uptake and compliance to surveillance programs.

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International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma https://clinicalvalue.com/en-au/international-liver-cancer-association-ilca-white-paper-on-biomarker-development-for-hepatocellular-carcinoma/ Tue, 14 Mar 2023 08:00:20 +0000 https://clinicalvalue.com/international-liver-cancer-association-ilca-white-paper-on-biomarker-development-for-hepatocellular-carcinoma/ This white paper, which was developed by a group of experts in biomarker development, provides a framework on best practices to design, execute, and interpret biomarker studies for risk stratification, early detection, diagnosis, prognostication, and treatment response assessment in HCC.

Singal AG, Hoshida Y, Pinato DJ, Marrero J, Nault JC, Paradis V, Tayob N, Sherman M, Lim YS, Feng Z, Lok AS, Rinaudo JA, Srivastava S, Llovet JM, Villanueva A...

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Quick Summary

ILCA logo

Biomarkers are biological molecules found in blood, other body fluids or tissues that can indicate a normal or abnormal process, condition, or disease. They play an important role in the clinical management of cancer patients by facilitating risk stratification, early detection, diagnosis, and prediction of prognosis or treatment response. In hepatocellular carcinoma (HCC), there is a need for better biomarkers to stratify patients at different stages of clinical management. Guidelines such as the Tumor Marker Utility Grading System (TMGUS) and the Reporting recommendations for tumor marker prognostic studies (REMARK) provide useful frameworks for biomarker development and validation in cancer. However, modifications may be required for specific clinical scenarios, such as risk stratification and treatment response assessment in HCC. To address these issues, the International Liver Cancer Association has assembled a group of experts on biomarker development to provide a framework on best practices for biomarker studies in HCC.

Authors: Amit G. Singal, Yujin Hoshida, David J. Pinato, Jorge Marrero, Jean-Charles Nault, Valerie Paradis, Nabihah Tayob, Morris Sherman, Young Suk Lim, Ziding Feng, Anna S. Lok, Jo Ann Rinaudo, Sudhir Srivastava, Josep Llovet, Augusto Villanueva

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