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Improvement of Diagnostic Sensitivity for Tumor Markers

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A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Clinical Laboratory Medicine".

Deadline for manuscript submissions: 16 June 2024 | Viewed by 3838

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Special Issue Editors

Dr. Jong-Han Lee

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Guest Editor

Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, Republic of Korea
Interests: laboratory medicine; diagnostic immunology; infection immunology; tumor immunology; transfusion medicine

Dr. Jooyoung Cho

E-Mail Website
Guest Editor

Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju 26426, Republic of Korea
Interests: laboratory medicine; diagnostic immunology; infection immunology; tumor immunology; transfusion medicine

Special Issue Information

Dear Colleagues,

The diagnosis of cancer is one of the most important issues in current laboratory medicine, as an early and exact diagnosis may greatly contribute to the management of the disease and survival of patients. In these days, there are many updated, new technologies that can be applied for cancer diagnosis. This section of Diagnostics aims to publish qualified new papers that cover various diagnostic efforts for effective cancer diagnosis. We are interested in updated, new technologies including molecular genetics and immunologic diagnosis for improving tumor marker sensitivity and specificity.

The scope of this Special Issue includes, but is not limited to:

Clinical study of tumor marker usage;
Tumor marker-related laboratory research;
Issues related to improving cancer diagnosis;
Translational research of cancer diagnosis;
New diagnostic technologies for cancer;
AI and big data sciences.

Dr. Jong-Han Lee
Dr. Jooyoung Cho
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

development of tumor markers
laboratory diagnosis
improving sensitivity and specificity
cancer disease
translational research
new diagnostic technologies for cancer
molecular genomics
immunologic diagnosis
clinical chemistry
clinical hematology
diagnostic microbiology
data science

Published Papers (3 papers)

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Research

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13 pages, 3574 KiB

Open AccessArticle

Longitudinal Evaluation of AFP and CEA External Proficiency Testing Reveals Need for Method Harmonization

by Nathalie Wojtalewicz, Laura Vierbaum, Anne Kaufmann, Ingo Schellenberg and Stefan Holdenrieder

Diagnostics 2023, 13(12), 2019; https://doi.org/10.3390/diagnostics13122019 - 09 Jun 2023

Cited by 4 | Viewed by 1248

Abstract

The glycoproteins alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA) have long been approved as biomarkers for diagnosing and monitoring tumors. International Reference Preparations (IRPs) have been around since 1975. Nevertheless, manufacturer-dependent differences have been reported, indicating a lack of harmonization. This paper analyzes data from 15 external quality assessment (EQA) surveys conducted worldwide between 2018 and 2022. The aim was to gain insight into the longitudinal development of manufacturer-dependent differences for CEA and AFP. In each survey, participating laboratories received two samples with different tumor marker levels. Inter- and intra-assay variability was analyzed and the mean 80% and 90% of the manufacturer collectives were compared to the evaluation criteria of the German Medical Association (RiliBÄK). The median EQA results for CEA revealed manufacturer-dependent differences between the highest and lowest collective of up to 100%; for AFP, the median differences mostly remained below 40%. The coefficients of variation were predominantly low for both markers. We concluded that the current assays for AFP and CEA detection are better harmonized than previously reported. The assays displayed a good robustness; however, a narrowing of the current assessment limits in EQA schemes could further enhance the quality of laboratory testing. Full article

(This article belongs to the Special Issue Improvement of Diagnostic Sensitivity for Tumor Markers)

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11 pages, 1400 KiB

Open AccessArticle

An m6A-Driven Prognostic Marker Panel for Renal Cell Carcinoma Based on the First Transcriptome-Wide m6A-seq

by Frank Waldbillig, Felix Bormann, Manuel Neuberger, Jörg Ellinger, Philipp Erben, Maximilian C. Kriegmair, Maurice Stephan Michel, Philipp Nuhn and Malin Nientiedt

Diagnostics 2023, 13(5), 823; https://doi.org/10.3390/diagnostics13050823 - 21 Feb 2023

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Abstract

To date, only a single transcriptome-wide m6A sequencing study of clear cell renal cell carcinoma (ccRCC) has been reported, with no validation so far. Herein, by TCGA analysis of the KIRC cohort (n = 530 ccRCC; n = 72 normal), an external expression validation of 35 preidentified m6A targets was performed. Further in-depth expression stratification enabled assessment of m6A-driven key targets. Overall survival (OS) analysis and gene set enrichment analyses (GSEA) were conducted to assess their clinical and functional impact on ccRCC. In the hyper-up cluster significant upregulation was confirmed for NDUFA4L2, NXPH4, SAA1, and PLOD2 (40%) and in the hypo-up cluster for FCHSD1 (10%). Significant downregulation was observed for UMOD, ANK3, and CNTFR (27.3%) in the hypo-down cluster and for CHDH (25%) in the hyper-down cluster. In-depth expression stratification showed consistent dysregulation in ccRCC only for 11.67%: NDUFA4L2, NXPH4, and UMOD (NNU-panel). Patients with strong NNU panel dysregulation had significantly poorer OS (p = 0.0075). GSEA identified 13 associated and significantly upregulated gene sets (all p-values < 0.5; FDR < 0.25). External validation of the only available m6A sequencing in ccRCC consistently reduced dysregulated m6A-driven targets on the NNU panel with highly significant effects on OS. Epitranscriptomics are a promising target for developing novel therapies and for identifying prognostic markers for daily clinical practice. Full article

(This article belongs to the Special Issue Improvement of Diagnostic Sensitivity for Tumor Markers)

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Review

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13 pages, 2083 KiB

Open AccessReview

Three-Dimensional Structure of Novel Liver Cancer Biomarker Liver Cancer-Specific Serine Protease Inhibitor Kazal (LC-SPIK) and Its Performance in Clinical Diagnosis of Hepatocellular Carcinoma (HCC)

by Felix Lu, Connor Ott, Prabha Bista and Xuanyong Lu

Diagnostics 2024, 14(7), 725; https://doi.org/10.3390/diagnostics14070725 - 29 Mar 2024

Viewed by 699

Abstract

LC-SPIK is a liver cancer-specific isoform of Serine Protease Inhibitor Kazal and has been proposed as a new biomarker for the detection of HCC given its unique 3D structure, which differs from normal pancreatic SPIK. An ELISA technology based on its unique structure was developed to use LC-SPIK as an effective biomarker for the clinical diagnosis of HCC. AFP, the most widely used biomarker for HCC surveillance currently, suffers from poor clinical performance, especially in the detection of early-stage HCC. In one case–control study, which included 164 HCC patients and 324 controls, LC-SPIK had an AUC of 0.87 compared to only 0.70 for AFP in distinguishing HCC from liver disease controls (cirrhosis, HBV/HCV). LC-SPIK also performed significantly better than AFP for the 81 patients with early-stage HCC (BCLC stage 0 and A), with an AUC of 0.85 compared to only 0.61 for AFP. Cirrhosis is the major risk factor for HCC; about 80% of patients with newly diagnosed HCC have preexisting cirrhosis. LC-SPIK’s clinical performance was also studied in HCC patients with viral and non-viral cirrhosis, including cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) and alcoholic liver disease (ALD). In a total of 163 viral cirrhosis patients with 93 HCC patients (50 early-stage), LC-SPIK had an AUC of 0.85, while AFP had an AUC of 0.70. For patients with early-stage HCC, LC-SPIK had a similar AUC of 0.83, while AFP had an AUC of only 0.60. For 120 patients with nonviral cirrhosis, including 62 HCC (23 early-stage) patients, LC-SPIK had an AUC of 0.84, while AFP had an AUC of only 0.72. For the 23 patients with early-stage HCC, LC-SPIK had a similar AUC of 0.83, while the AUC for AFP decreased to 0.65. All these results suggest that LC-SPIK exhibits significantly better performance in the detection of HCC than AFP in all etiologies of liver diseases. In addition, LC-SPIK accurately detected the presence of HCC in 71–91% of HCC patients with false-negative AFP test results in viral-associated HCC and non-viral-associated HCC. Full article

(This article belongs to the Special Issue Improvement of Diagnostic Sensitivity for Tumor Markers)

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