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Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early-Stage Pancreatic Cancer
Open accessAbstract
PURPOSE: Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with a 5-year survival of < 10% because of diffuse symptoms leading to late-stage diagnosis. That survival could increase significantly if localized tumors could be detected early. Therefore, we used multiparametric analysis of blood samples to obtain a novel biomarker signature of early-stage PDAC. The signature was derived from a large patient cohort, including patients with well-defined early-stage (I and II) PDAC. This biomarker signature was validated subsequently in an independent patient cohort. PATIENTS AND METHODS: The biomarker signature was derived from a case-control study, using a Scandinavian cohort, consisting of 16 patients with stage I, 132 patients with stage II, 65 patients with stage III, and 230 patients with stage IV PDAC, and 888 controls. This signature was validated subsequently in an independent case-control cohort in the United States with 15 patients with stage I, 75 patients with stage II, 15 patients with stage III, and 38 patients with stage IV PDAC, and 219 controls. An antibody microarray platform was used to identify the serum biomarker signature associated with early-stage PDAC. RESULTS: Using the Scandinavian case-control study, a biomarker signature was created, discriminating samples derived from patients with stage I and II from those from controls with a receiver operating characteristic area under the curve value of 0.96. This signature, consisting of 29 biomarkers, was then validated in an independent case-control study in the United States. The biomarker signature could discriminate patients with stage I and II PDAC from controls in this independent patient cohort with a receiver operating characteristic area under the curve value of 0.96. CONCLUSION: This serum biomarker signature might represent a tenable approach to detecting early-stage, localized PDAC if these findings are supported by a prospective validation study.
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“[12] drew a similar conclusion, based on a serum biomarker panel comprising 29 proteins, which showed the ability to discriminate early stage PDAC from control samples without inclusion of CA19-9.”
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Liquid Biopsy is Instrumental for 3PM Dimensional Solutions in Cancer Management
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Ying, L., Sharma, A. R., Chhoda, A., Ruzgar, N. M., Hasan, N. M., Kwak, R., Wolfgang, C. L., Wang, T., Kunstman, J. W., Salem, R. R., et al. (2021) · Pancreas · doi:10.1097/mpa.0000000000001919 · Cited by 37
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He, R., Shi, J., Xu, D., Yang, J., Shen, Y., Jiang, Y., Tao, L., Yang, M., Fu, X., Yang, J., et al. (2022) · Cancer Letters · doi:10.1016/j.canlet.2022.215693 · Cited by 33
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Is screening for pancreatic cancer in high-risk individuals one step closer or a fool's errand?
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Innate and adaptive immune-directed tumour microenvironment in pancreatic ductal adenocarcinoma
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“17 markers we compared the performance of our marker with each study [Bhasin et al (7), Balasenthil 357 et al (20), Kisiel et al (21) and Immunovia (22)] .”
ResultGallo, M., Adinolfi, V., Morviducci, L., Acquati, S., Tuveri, E., Ferrari, P., Zatelli, M. C., Faggiano, A., Argentiero, A., Natalicchio, A., et al. (2021) · ESMO Open · doi:10.1016/j.esmoop.2021.100155 · Cited by 33
“This assessment succeeded in detecting 64% of resectable PCs. Mellby et al. 49 carried out a large proteomic study on > 1700 case-control samples to fi nd out a biomarker signature enabling early PC detection: the group selected a panel of 29 biomarkers (CA19-9 was not included) (Table 4) that has…”
BackgroundMulti‐biomarker panel prediction model for diagnosis of pancreatic cancer
Lee, D., Yoon, W., Lee, A., Han, Y., Byun, Y., Kang, J. S., Kim, H., Kwon, W., Suh, Y., Choi, Y., et al. (2021) · Journal of Hepato-Biliary-Pancreatic Sciences · doi:10.1002/jhbp.986 · Cited by 32
Serum biomarker-based early detection of pancreatic ductal adenocarcinomas with ensemble learning
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“Of note, several clinical studies are currently ongoing, including a large (5000 patients), prospective, observational, longitudinal study BIOmarkers in Patients With Pancreatic Cancer (BIOPAC), NCT03311776, which has already published initial results with Biomarkers Consensus Signature, although miRNAs have not yet b…”
BackgroundA Serum Marker for Early Pancreatic Cancer With a Possible Link to Diabetes
Nam, H., Hong, S., Jung, K. H., Kang, S., Park, M. S., Kang, S., Kim, H. S., Mai, V.-H., Kim, J., Lee, H., et al. (2021) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djab191 · Cited by 29
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“The comprehensive analysis contributes to more accurately explore the potential molecular mechanisms of different diseases, and may promote the future clinical research [15–17].”
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Plasma protein biomarkers for early detection of pancreatic ductal adenocarcinoma
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“We identified two panels of features for prediction modeling in (a) early PDAC patients vs healthy controls and (b) advanced PDAC patients vs healthy controls with a two-step method inspired by a previous study.(20) Briefly, backward elimination regression(21) was conducted to select a panel of features among 96 varia…”
MethodBestari, M. B., Joewono, I. R., & Syam, A. F. (2024) · Biomolecules · doi:10.3390/biom14030364 · Cited by 24
“The biomarker signatures, comprising 29 biomarkers, demonstrated an AUC of 0.96 [83].”
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“Considering the availability of body fluids, the so-called liquid biopsy, including plasma, serum, and urine, has been intensively investigated to meet the clinical needs and patients’ benefit by useful biomarkers for pancreatic cancer [10-15].”
BackgroundStosic, K., Senar, O. A., Tarfouss, J., Bouchart, C., Navez, J., Laethem, J. V., & Arsenijevic, T. (2023) · Cells · doi:10.3390/cells13010003 · Cited by 22
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“A separate study identified a signature of 29 biomarkers capable of distinguishing early-stage PC with an AUC of 0.96 (95% CI: 0.94–0.98), 93% sensitivity, and 95% specificity (59).”
InfluentialDeep Learning Improves Pancreatic Cancer Diagnosis Using RNA-Based Variants
Al-Fatlawi, A. H., Malekian, N., García, S. A., Henschel, A., Kim, I., Dahl, A., Jahnke, B., Bailey, P. J., Bolz, S. N., Poetsch, A. R., et al. (2021) · Cancers · doi:10.3390/cancers13112654 · Cited by 21
“However, combinations of biomarkers or variants [7,15,18,19] promise improvements.”
BackgroundResultDistinguishing diabetes secondary to pancreatic diseases from type 2 diabetes mellitus
Hart, P. A., Andersen, D. K., Petrov, M. S., & Goodarzi, M. O. (2021) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000000754 · Cited by 21
Diagnostic biomarkers for pancreatic cancer: An update
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Zhou, Q., Andersson, R. E., Hu, D., Bauden, M. P., Sasor, A., Bygott, T., Pawłowski, K., Plá, I., Marko‐Varga, G., & Ansari, D. (2019) · Translational research · doi:10.1016/j.trsl.2019.06.003 · Cited by 21
Excessive risk of second-cancer incidence and cancer mortality in patients with esophageal cancer
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“However, some promising methods for early detection are being developed for this cancer [34, 35].”
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“In contrast, plasma can serve as a low-cost and highly accessible source for biomarker discovery and extract multiple times during the disease course, providing longitudinal information and exhibiting valuable changes.[23,24] A liquid biopsy also contains a broad range of biological specimens, including circulating tu…”
BackgroundA robust 6-mRNA signature for prognosis prediction of pancreatic ductal adenocarcinoma
Zhou, C., Zhao, Y., Yin, Y., Hu, Z., Atyah, M. M., Chen, W., Meng, Z., Mao, H., Zhou, Q., Tang, W., et al. (2019) · International Journal of Biological Sciences · doi:10.7150/ijbs.32899 · Cited by 19
Potential biomarkers for early detection of pancreatic ductal adenocarcinoma
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“Current tumor markers, such as cancer antigen (CA) 19–9, are insufficient for early PAAD detection or prognosis prediction [1].”
BackgroundAthanasiou, A., Kureshi, N. M., Wittig, A., Sterner, M., Huber, R., Palma, N. A., King, T. C., & Schiess, R. (2024) · Journal of Proteome Research · doi:10.1021/acs.jproteome.4c00752 · Cited by 18
Fluorescence Signal Enhancement in Antibody Microarrays Using Lightguiding Nanowires
Verardo, D., Liljedahl, L., Richter, C., Agnarsson, B., Axelsson, U., Prinz, C. N., Höök, F., Borrebaeck, C. A. K., & Linke, H. (2021) · Nanomaterials · doi:10.3390/nano11010227 · Cited by 17
“In this work, we therefore use these measures to assess the capacity of SiO2-coated GaP nanowires for the detection of biomarkers using a well-established immunoassay originally designed for flat surfaces [26] and proven capable of identifying unique biomarker signatures for cancer diagnostics [27,28].”
MethodTurner, K. M., Delman, A. M., Ammann, A. M., Sohal, D. P. S., Olowokure, O. O., Choe, K. A., Smith, M. T., Kharofa, J. R., Ahmad, S. A., Wilson, G. C., et al. (2022) · Annals of Surgical Oncology · doi:10.1245/s10434-022-11580-7 · Cited by 16
“Serum biomarker signatures and changes in circulating cell-free DNA represent novel platforms that offer potential as screening tools, possibly further increasing this trend.(21,22) Multiple previous trials have demonstrated the benefit of both single agent and multi-agent AC in patients with resected PDAC; however, S…”
BackgroundMason, J. E., Lundberg, E., Jonsson, P., Nyström, H., Franklin, O., Lundin, C., Naredi, P. L. J., Antti, H., Sund, M., & Öhlund, D. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232112969 · Cited by 17
“Using elevated circulating proteins as early detection biomarkers for PDAC appears difficult, although holistic approaches yield some promise [30], where recently a panel of 29 serum biomarkers was identified that could distinguish stage I and II PDAC patients from controls using samples at diagnosis.”
BackgroundTumor-Derived Biomarkers in Liquid Biopsy of Glioblastoma
Khristov, V., Lin, A. C., Freedman, Z., Staub, J., Shenoy, G., Mrowczynski, O., Rizk, E., Zacharia, B. E., & Connor, J. R. (2022) · World Neurosurgery · doi:10.1016/j.wneu.2022.11.012 · Cited by 16
Tanaka, H., Tamura, K., Abe, T., Yoshida, T., Macgregor-Das, A. M., Dbouk, M. H., Blackford, A. L., Borges, M. W., Lennon, A. M., He, J. P., et al. (2021) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.10.008 · Cited by 15
Towards a Personalized Approach in Pancreatic Cancer Diagnostics Through Plasma Amino Acid Analysis
Tumas, J., Baskirova, I., Petrėnas, T., Norkūnienė, J., Strupas, K., & Šileikis, A. (2019) · Anticancer Research · doi:10.21873/anticanres.13314 · Cited by 15
Xiong, F., Wu, G., Wang, B., & Chen, Y. (2021) · Cancer Cell International · doi:10.1186/s12935-021-02117-1 · Cited by 15
“To date, there have been numerous studies investigating biomarkers for PDA, including single markers [31] multiple biomarker panels [32], and immunebased proteomic panels [33].”
BackgroundRecent advances in the use of liquid biopsy to fight central nervous system tumors
Heming, C. P., Filho, P. N., Moura‐Neto, V., & Aran, V. (2023) · Cancer Treatment and Research Communications · doi:10.1016/j.ctarc.2023.100709 · Cited by 13
Liquid biopsies and exosomal ncRNA: Transforming pancreatic cancer diagnostics and therapeutics
Balaraman, A. K., Moglad, E. H. O., Afzal, M., Babu, M. A., Goyal, K., Roopashree, R., Kaur, I., Kumar, S., Kumar, M., Chauhan, A. S., et al. (2024) · Clinica Chimica Acta · doi:10.1016/j.cca.2024.120105 · Cited by 14
Calanzani, N., Druce, P., Snudden, C. M., Milley, K. M., Boscott, R. A., Behiyat, D., Saji, S., Martínez-Gutiérrez, J., Oberoi, J., Funston, G., et al. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01571-z · Cited by 13
Mottini, C., Auciello, F. R., Manni, I., Pilarsky, C. P., Caputo, D. D., Caracciolo, G., Rossetta, A., Gennaro, E. D., Budillon, A., Blandino, G., et al. (2024) · Journal of Experimental & Clinical Cancer Research · doi:10.1186/s13046-024-03117-5 · Cited by 12
“Among the studies that aim to evaluate circulating proteins the most successful clinical trial was the one that presented a consensus signature comprising of 29 biomarkers capable of discriminating between healthy individuals and those with PC in stages I and II [134] (Table I).”
BackgroundUsing Endoscopic Optical Coherence Tomography to Detect and Treat Early-Stage Pancreatic Cancers
Lu, L., Hu, Z., Frankel, W. L., Shen, R. Z., Chen, W., Pan, X. J., Grecula, J. C., Bloomston, M. P., & Dillhoff, M. E. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.591484 · Cited by 12
“2 mm) attached to an optical fiber that transfers the illuminating light and signal between the source and the receiving optical spectrometer, Figure 4A; (2) broad bandwidth NIR light source, Figure 4C; (3) the soft and transparent OCT catheter tube (inner diameter: 1 mm; outer diameter: 2 mm) that allows the OCT prob…”
BackgroundMolecular Approaches Using Body Fluid for the Early Detection of Pancreatic Cancer
Satoh, K. (2021) · Diagnostics · doi:10.3390/diagnostics11020375 · Cited by 12
Diagnostic model for pancreatic cancer using a multi-biomarker panel
Choi, Y. J., Yoon, W., Lee, A., Han, Y., Byun, Y., Kang, J. S., Kim, H., Kwon, W., Suh, Y., Kim, Y., et al. (2021) · Annals of Surgical Treatment and Research · doi:10.4174/astr.2021.100.3.144 · Cited by 12
“Recently, 2 studies developed a serum multi-biomarker microarray for the early detection of PDAC that went through external validation on a large cohort [19,20].”
Chen, J., Zheng, Y., Wang, Z., Gao, Q., Hao, K., Chen, X., Ke, N., Lv, X., Weng, J., Zhong, Y., et al. (2025) · BMC Medicine · doi:10.1186/s12916-025-03871-z · Cited by 12
Lu, Y., Zhou, X., Zhou, C., Liu, J., Yong, T., Fan, Y., & Wang, C. (2022) · Human Cell · doi:10.1007/s13577-022-00770-w · Cited by 11
“1 3 PC is expected to become the second leading cause of cancer death by 2030 [20].”
BackgroundGreco, L., Rubbino, F., & Laghi, L. (2022) · Cancers · doi:10.3390/cancers14235797 · Cited by 13
Successively triggered Rod-shaped protocells for enhanced tumor Chemo-Photothermal therapy
Zhang, W., Chen, L., Cui, M., Xie, L., Xi, Z., Wang, Y., Shen, X., & Xu, L. (2021) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2021.08.012 · Cited by 11
Rodríguez, E., Zwart, E. S., Affandi, A. J., Verhoeff, J., de Kok, M., Boyd, L. N. C., Meijer, L. L., Large, T. Y. S. L., Olesek, K., Giovannetti, E., et al. (2024) · Cancer Science · doi:10.1111/cas.16147 · Cited by 9
Wu, Y., Qiao, Y., Yang, C., Chen, Y., Shen, X., Deng, C., Yao, Q., & Sun, N. (2024) · Small Methods · doi:10.1002/smtd.202401238 · Cited by 10
Hermoso‐Durán, S., Fraunhoffer, N. A., Millastre‐Bocos, J., Sanchez‐Gracia, O., Garrido, P. F., Vega, S., Lanas, Á., Iovanna, J., Velázquez‐Campoy, A., & Abián, O. (2024) · Advanced Intelligent Systems · doi:10.1002/aisy.202400308 · Cited by 10
Mukherjee, S., Sundfeldt, K., Borrebaeck, C. A. K., & Jakobsson, M. E. (2021) · Proteomes · doi:10.3390/proteomes9020025 · Cited by 10
“Antibody-microarrays have developed to the point where very high test accuracy can be achieved, as is illustrated by the detection of early-stage pancreatic cancer [112].”
BackgroundZhu, Z., Xiao, S., Hao, H., Hou, Q., & Fu, X. (2019) · Current Topics in Medicinal Chemistry · doi:10.2174/1568026619666190828160804 · Cited by 10
Pancreatic Cancer Surveillance and Novel Strategies for Screening
Dudley, B., & Brand, R. E. (2021) · Gastrointestinal Endoscopy Clinics of North America · doi:10.1016/j.giec.2021.08.008 · Cited by 10
Juthani, R., & Manne, A. (2025) · Frontiers in Oncology · doi:10.3389/fonc.2025.1555963 · Cited by 12
Earl, J., Barreto, E., Castillo, M., Fuentes, R., Rodríguez-Garrote, M., Ferreiro, R., Reguera, P., Muñoz, G., García‐Seisdedos, D., López, J., et al. (2021) · Cancers · doi:10.3390/cancers13071612 · Cited by 10
“Several potential biomarkers have been recently described such as a three-protein panel in urine [11], Galectin-1 (Gal-1) in serum [12], thrombospondin-2 (THBS2) in plasma [13], circulating tumor DNA (ctDNA) [14], and the IMMrayTM PanCan-d 29 biomarker signature in serum [15].”
BackgroundBiomarkers for Early Detection of Pancreatic Cancer: A Review
Dodda, K., & Muneeswari, G. (2023) · International Conference on Signal Processing, Computation, Electronics, Power and Telecommunication (IConSCEPT) · doi:10.1109/iconscept57958.2023.10170123 · Cited by 9
Löhr, M. J., Öhlund, D., Söreskog, E., Andersson, E., Vujasinović, M., Zethraeus, N., & Sund, M. (2024) · Familial Cancer · doi:10.1007/s10689-024-00363-6 · Cited by 9
Mizuno, S., Isayama, H., Nakai, Y., Ishigaki, K., Saito, K., Sato, T., Takeda, T., Hakuta, R., Saito, T., Takahara, N., et al. (2019) · Pancreatology · doi:10.1016/j.pan.2019.07.002 · Cited by 9
Liquid Biopsy: A Biomarker-Driven Tool towards Precision Oncology
Yee, N. S. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9082556 · Cited by 9
Kim, H.-S., Chu, J., Do, I., Lee, Y., Kim, H. K., Yang, Y., Kwon, J., Lee, K. H., Bat‐Ochir, C., Jo, E., et al. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1395473 · Cited by 8
“Diagnostic methods for PDAC have previously been studied (10, 16, 23, 24).”
MethodIdentification of PRTN3 as a novel biomarker for the diagnosis of early gastric cance
Guo, D., Zhang, B., Wu, D., Hu, X., & Tu, H. (2023) · Journal of Proteomics · doi:10.1016/j.jprot.2023.104852 · Cited by 7
Kim, H., Huh, S., Park, J., Han, Y., Ahn, K.-G., Noh, Y., Lee, S.-J., Chu, H., Kim, S., Jung, H., et al. (2024) · Molecular & Cellular Proteomics · doi:10.1016/j.mcpro.2024.100824 · Cited by 7
“Due to these limitations of the pre-sent screening methods, efforts have been underway to develop and implement novel diagnostic assays for PDAC (5 – 7).”
MethodChallenges in the Clinical Application of Machine Learning for Pancreatic Cancer
Večurkovská, I., Roškovičová, V., & Kaťuchová, J. (2025) · Bratislavské lekárske listy/Bratislava medical journal · doi:10.1007/s44411-025-00312-4 · Cited by 9
“Melby et al. [39] achieved similar values, namely 94% and 95%, in a case–control study with a larger number of probands (PDAC 443/healthy 888).”
Hu, X., Tan, W., Cheng, S., Xian, Y., & Zhang, C. (2023) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-022-04509-2 · Cited by 7
Liquid biomarkers in prostate cancer: recent advancements and future directions
Wong, C. H. M., Ko, I. C., & Ng, C. (2024) · Current Opinion in Urology · doi:10.1097/mou.0000000000001188 · Cited by 7
“These variables can affect the concentration and detection of biomarkers [51].”
Qi, L., Li, X., Ni, J., Du, Y., Gu, Q., Liu, B., He, J., & Du, J. (2025) · Cancer Cell International · doi:10.1186/s12935-025-03639-8 · Cited by 6
“Technologies such as radiomics, genomics, and liquid biopsy play a crucial role in the precision treatment of tumors, leveraging computer technology and artificial intelligence algorithms [3, 6–8].”
Metadata
- Authors
- Mellby, L. D., Nyberg, A. P., Johansen, J. S., Wingren, C., Nordestgaard, B. G., Bojesen, S. E., Mitchell, B. L., Sheppard, B. C., Sears, R. C., & Borrebaeck, C. A. K.
- Affiliations
- University of Copenhagen (DK)
- Corresponding author
- Borrebaeck, Carl A.K.
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2018-10-01
- Volume
- 36
- Issue
- 28
- Pages
- 2887-2894
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC6161836
- OpenAlex
- W2887694233
- Cited by
- 159
- References
- 52
- Citations by year
- 2026: 10 · 2025: 13 · 2024: 20 · 2023: 17 · 2022: 20 · 2021: 39 · 2020: 25 · 2019: 13 · 2018: 2
- FWCI
- 7.50
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Funders
- Gentofte Hospital
- Rigshospitalet
- National Institutes of Health (UL1TR002369)
- National Cancer Institute (R01CA196228, R01CA186241)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
- Keywords
- pancreatic ductal adenocarcinoma, early-stage pancreatic cancer, liquid biopsy, cancer detection, antibody microarrays, diagnostic biomarkers, tumor staging
- MeSH terms
- Liquid Biopsy, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Pancreatic Neoplasms, Retrospective Studies, Sensitivity and Specificity, Biomarkers, Tumor, Cohort Studies, Case-Control Studies, Carcinoma, Pancreatic Ductal
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