Uncategorized – Clinical Value of Diagnostics https://clinicalvalue.com Thu, 28 Mar 2024 09:09:46 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.3 https://i0.wp.com/clinicalvalue.com/wp-content/uploads/2023/01/apple-touch-icon.png?fit=32%2C32&ssl=1 Uncategorized – Clinical Value of Diagnostics https://clinicalvalue.com 32 32 225041835 Thank you for your interest! https://clinicalvalue.com/hcc-detection-expert-pack-thank-you-page/ Thu, 17 Aug 2023 09:41:43 +0000 https://clinicalvalue.com/?p=7188 ...

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Your HD expert pack is ready for download. Please click the buttons below to download your pdf copy of the HD expert pack materials.

Highlights from the 2022 APAC regional consensus


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2022 APAC regional consensus publication


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2023 APASL congress report



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Stay tuned for updates in the liver space, including future studies and patient cases.

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Get the latest updates in the liver space with our HCC detection (HD) expert pack https://clinicalvalue.com/hcc-detection-expert-pack/ Fri, 28 Jul 2023 03:13:28 +0000 https://clinicalvalue.com/?p=7014 ...

The post Get the latest updates in the liver space with our HCC detection (HD) expert pack appeared first on Clinical Value of Diagnostics.

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Get the latest updates in the liver space with our HCC detection (HD) expert pack

Includes

  • Highlights and a PDF copy of the latest APAC regional consensus for PIVKA-II and AFP in HCC
  • APASL 2023 Congress Report
  • Updates on future studies and patient cases
Frame 118

About 1 in 3 early hepatocellular carcinoma (HCC) patients
are missed with current standard of care 1

 
patients image
 

Ultrasound + AFP has only 63% sensitivity in detecting early stage HCC2

37% are missed

This means that 37% patients are missing out on potentially curative HCC treatment.

Download the free HD expert pack

The gaps in current standard of care

HCC detection US icon

Ultrasound3

  • Operator variability
  • Poor performance in patients with fibrotic changes and fatty infiltration of the liver
  • Difficult to perform on obese patients 
  • Difficult to detect small tumors (< 2cm)
  • Limited capacity in public hospitals and rural settings
HCC detection AFP icon

AFP3-5

Sensitivity and specificity depends on cut-off values used AFP can be elevated (false positive) in:
  • Cirrhosis
  • Active hepatitis
  • Other types of tumors
AFP can be normal (false negative) in:
  • Certain HCC patients have normal AFP throughout the entire disease course. This can be dependent on the etiology of the disease (e.g. high prevalence of AFP-negative in patients with fatty liver disease  induced HCC)
  • Small HCC tumors (<2cm)

PIVKA-II + AFP improves detection of early HCC with increased sensitivity compared to AFP alone

PIVKA-II is a protein that is elevated in the liver under certain circumstances, such as HCC and Vitamin K deficiency6,7.

HCC Dection cc PIVKA II graphic

In the recent 2022 'Utility of combining PIVKA-II and AFP in the surveillance and monitoring of hepatocellular carcinoma in the Asia-Pacific region', experts agree that PIVKA-II, when combined with AFP, improves the detection of HCC, compared to either biomarker alone4.

HCC detection all stage
HCC detection early stage

Experts also agree that PIVKA-II is valuable in the detection of HCC in AFP-negative HCC patients4.

Many patients with HCC are AFP-negative (defined as AFP ≤20 ng/ml)

HCC Dection cc Pie chart
HCC AFP mobile

Almost Half (46%) of 1,158 patients with HCC were AFP-negative10

PIVKA-II can detect up to 76% of patients with AFP-negative HCC11

Sensitivity

HCC detection 76 ai 1

Specificity

HCC detection 89 ai 1

AUC

HCC detection 86 ai 1

References:

  1. Hanouneh, I. A., Alkhouri, N., & Singal, A. G. (2019). Hepatocellular carcinoma surveillance in the 21st century: Saving lives or causing harm?. Clinical and molecular hepatology, 25(3), 264–269. https://doi.org/10.3350/cmh.2019.1001
  2. Tzartzeva, K., Obi, J., Rich, N. E., Parikh, N. D., Marrero, J. A., Yopp, A., Waljee, A. K., & Singal, A. G. (2018). Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology, 154(6), 1706–1718.e1. https://doi.org/10.1053/j.gastro.2018.01.064
  3. Simmons, O., Fetzer, D. T., Yokoo, T., Marrero, J. A., Yopp, A., Kono, Y., Parikh, N. D., Browning, T., & Singal, A. G. (2017). Predictors of adequate ultrasound quality for hepatocellular carcinoma surveillance in patients with cirrhosis. Alimentary pharmacology & therapeutics, 45(1), 169–177. https://doi.org/10.1111/apt.13841
  4. Kim, D. Y., Toan, B. N., Tan, C. K., Hasan, I., Setiawan, L., Yu, M. L., Izumi, N., Huyen, N. N., Chow, P. K., Mohamed, R., Chan, S. L., Tanwandee, T., Lee, T. Y., Hai, T. T. N., Yang, T., Lee, W. C., & Chan, H. L. Y. (2023). Utility of combining PIVKA-II and AFP in the surveillance and monitoring of hepatocellular carcinoma in the Asia-Pacific region. Clinical and molecular hepatology, 29(2), 277–292. https://doi.org/10.3350/cmh.2022.0212
  5. Tokushige, K., Hyogo, H., Nakajima, T., Ono, M., Kawaguchi, T., Honda, K., Eguchi, Y., Nozaki, Y., Kawanaka, M., Tanaka, S., Imajo, K., Sumida, Y., Kamada, Y., Fujii, H., Suzuki, Y., Kogiso, T., Karino, Y., Munekage, K., Kuromatsu, R., Oeda, S., … Hashimoto, E. (2016). Hepatocellular carcinoma in Japanese patients with nonalcoholic fatty liver disease and alcoholic liver disease: multicenter survey. Journal of gastroenterology, 51(6), 586–596. https://doi.org/10.1007/s00535-015-1129-1
  6. Liebman, H. A., Furie, B. C., Tong, M. J., Blanchard, R. A., Lo, K. J., Lee, S. D., Coleman, M. S., & Furie, B. (1984). Des-gamma-carboxy (abnormal) prothrombin as a serum marker of primary hepatocellular carcinoma. The New England journal of medicine, 310(22), 1427–1431. https://doi.org/10.1056/NEJM198405313102204
  7. Ono, M., Ohta, H., Ohhira, M., Sekiya, C., & Namiki, M. (1990). Measurement of immunoreactive prothrombin precursor and vitamin-K-dependent gamma-carboxylation in human hepatocellular carcinoma tissues: decreased carboxylation of prothrombin precursor as a cause of des-gamma-carboxyprothrombin synthesis. Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine, 11(6), 319–326. https://doi.org/10.1159/000217667 
  8. Chen, H., Chen, S., Li, S., Chen, Z., Zhu, X., Dai, M., Kong, L., Lv, X., Huang, Z., & Qin, X. (2017). Combining des-gamma-carboxyprothrombin and alpha-fetoprotein for hepatocellular carcinoma diagnosing: an update meta-analysis and validation study. Oncotarget, 8(52), 90390–90401. https://doi.org/10.18632/oncotarget.20153 
  9. Xu, F., Zhang, L., He, W., Song, D., Ji, X., & Shao, J. (2021). The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients. Disease markers, 2021, 8868370. https://doi.org/10.1155/2021/8868370
  10. Farinati, F., Marino, D., De Giorgio, M., Baldan, A., Cantarini, M., Cursaro, C., Rapaccini, G., Del Poggio, P., Di Nolfo, M. A., Benvegnù, L., Zoli, M., Borzio, F., Bernardi, M., & Trevisani, F. (2006). Diagnostic and prognostic role of alpha-fetoprotein in hepatocellular carcinoma: both or neither?. The American journal of gastroenterology, 101(3), 524–532. https://doi.org/10.1111/j.1572-0241.2006.00443.x
  11. Ji, J., Wang, H., Li, Y., Zheng, L., Yin, Y., Zou, Z., Zhou, F., Zhou, W., Shen, F., & Gao, C. (2016). Diagnostic Evaluation of Des-Gamma-Carboxy Prothrombin versus α-Fetoprotein for Hepatitis B Virus-Related Hepatocellular Carcinoma in China: A Large-Scale, Multicentre Study. PloS one, 11(4), e0153227. https://doi.org/10.1371/journal.pone.0153227

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Expert Consensus Recommendations on Biomarker Testing in Metastatic and Non metastatic NSCLC in Asia https://clinicalvalue.com/expert-consensus-recommendations-on-biomarker-testing-in-metastatic-and-non-metastatic-nsclc-in-asia/ Fri, 19 May 2023 09:21:57 +0000 https://clinicalvalue.com/?p=6841 This report provides consensus recommendations for NSCLC biomarker testing from Asian lung cancer experts for clinicians working in Asia to improve patient care. Biomarker testing approaches for actionable genetic alterations in EGFR, ALK, ROS1, and others are discussed for nonmetastatic and metastatic forms of adenocarcinoma and squamous cell carcinoma....

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Quick Summary

IASLC logo

Most published guidelines for genomic biomarker testing in NSCLC reflect the disease epidemiology and treatments readily available in Europe and North America. Nevertheless, 60% of annual global NSCLC cases occur in Asia, where patient characteristics, tumor molecular profiles, and treatments vary greatly from the Western world. For example, mutations in the EGFR occur at a higher prevalence in Asia than in other world regions. Although medical associations such as the International Association for the Study of Lung Cancer, European Society for Medical Oncology, and American Society of Clinical Oncology have described principles for tumor genomic biomarker testing in NSCLC, there is a need for recommendations specific for Asia.

 

This report provides consensus recommendations for NSCLC biomarker testing from Asian lung cancer experts for clinicians working in Asia to improve patient care. Biomarker testing approaches for actionable genetic alterations in EGFR, ALK, ROS1, and others are discussed for nonmetastatic and metastatic forms of adenocarcinoma and squamous cell carcinoma.

The post Expert Consensus Recommendations on Biomarker Testing in Metastatic and Non metastatic NSCLC in Asia appeared first on Clinical Value of Diagnostics.

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Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group https://clinicalvalue.com/recommendations-for-the-use-of-next-generation-sequencing-and-the-molecular-tumor-board-for-patients-with-advanced-cancer-a-report-from-ksmo-and-kcsg-precision-medicine-networking-group/ Fri, 19 May 2023 09:14:58 +0000 https://clinicalvalue.com/?p=6792 These recommendations provide a critical guidance from NGS panel testing to final treatment decision based on MTB discussion....

The post Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group appeared first on Clinical Value of Diagnostics.

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Quick Summary

Next-generation sequencing (NGS) is becoming essential in the fields of precision oncology. With implementation of NGS in daily clinics, the needs for continued education, facilitated interpretation of NGS results and optimal treatment delivery based on NGS results have been addressed. Molecular tumor board (MTB) is a multidisciplinary approach to keep pace with the growing knowledge of complex molecular alterations in patients with advanced solid cancer. The purpose of these recommendations is to: 

  • provide an opportunity to share relevant clinical insights and experience among experts through the treatment guidelines development process
  • suggest a systematic process to oncology experts when conducting NGS tests, interpreting results, and making relevant therapeutic decisions
  • help determine the optimal treatment strategies through multidisciplinary approaches by suggesting the effective operation of the MTB.

The post Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group appeared first on Clinical Value of Diagnostics.

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