Cited by 208Pancreatic and Hepatic Oncology ResearchPancreatitis Pathology and TreatmentCancer Genomics and Diagnostics

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Lead-Time Trajectory of CA19-9 as an Anchor Marker for Pancreatic Cancer Early Detection

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Fahrmann, Johannes F., Schmidt, C. Max, Mao, Xiangying, Irajizad, Ehsan, Loftus, Maureen, Zhang, Jinming, Patel, Nikul, Vykoukal, Jody, Dennison, Jennifer B., Long, James P., Do, Kim-Anh, Zhang, Jianjun, Chabot, John A., Kluger, Michael D., Kastrinos, Fay, Brais, Lauren, Babic, Ana, Jajoo, Kunal, Lee, Linda S., Clancy, Thomas E., Ng, Kimmie, Bullock, Andrea, Genkinger, Jeanine, Yip-Schneider, Michele T., Maitra, Anirban, Wolpin, Brian M., Hanash, Samir·2021·Gastroenterology

DOI 10.1053/j.gastro.2020.11.052PMC PMC8783758

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Abstract

Background & aims There is substantial interest in liquid biopsy approaches for cancer early detection among subjects at risk, using multi-marker panels. CA19-9 is an established circulating biomarker for pancreatic cancer; however, its relevance for pancreatic cancer early detection or for monitoring subjects at risk has not been established.Methods CA19-9 levels were assessed in blinded sera from 175 subjects collected up to 5 years before diagnosis of pancreatic cancer and from 875 matched controls from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. For comparison of performance, CA19-9 was assayed in blinded independent sets of samples collected at diagnosis from 129 subjects with resectable pancreatic cancer and 275 controls (100 healthy subjects; 50 with chronic pancreatitis; and 125 with noncancerous pancreatic cysts). The complementary value of 2 additional protein markers, TIMP1 and LRG1, was determined.Results In the PLCO cohort, levels of CA19-9 increased exponentially starting at 2 years before diagnosis with sensitivities reaching 60% at 99% specificity within 0 to 6 months before diagnosis for all cases and 50% at 99% specificity for cases diagnosed with early-stage disease. Performance was comparable for distinguishing newly diagnosed cases with resectable pancreatic cancer from healthy controls (64% sensitivity at 99% specificity). Comparison of resectable pancreatic cancer cases to subjects with chronic pancreatitis yielded 46% sensitivity at 99% specificity and for subjects with noncancerous cysts, 30% sensitivity at 99% specificity. For prediagnostic cases below cutoff value for CA19-9, the combination with LRG1 and TIMP1 yielded an increment of 13.2% in sensitivity at 99% specificity (P = .031) in identifying cases diagnosed within 1 year of blood collection.Conclusion CA19-9 can serve as an anchor marker for pancreatic cancer early detection applications.

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Authors: Fahrmann, J. F., Schmidt, C. M., Mao, X., Irajizad, E., Loftus, M., Zhang, J., Patel, N., Vykoukal, J., Dennison, J. B., Long, J. P., Do, K.-A., Zhang, J., Chabot, J. A., Kluger, M. D., Kastrinos, F., Brais, L., Babic, A., Jajoo, K., Lee, L. S., Clancy, T. E., Ng, K., Bullock, A., Genkinger, J., Yip-Schneider, M. T., Maitra, A., Wolpin, B. M., & Hanash, S.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
Indiana University School of Medicine (US)
Harvard University (US)
Columbia University Irving Medical Center (US)
Brigham and Women's Hospital (US)
Beth Israel Deaconess Medical Center (US)
Corresponding author: Hanash, Samir
ORCID: Fahrmann, Johannes F.
Schmidt, C. Max
Mao, Xiangying
Irajizad, Ehsan
Loftus, Maureen
Zhang, Jinming
Dennison, Jennifer B.
Long, James P.
Do, Kim-Anh
Zhang, Jianjun
Kluger, Michael D.
Kastrinos, Fay
Brais, Lauren
Lee, Linda S.
Clancy, Thomas E.
Ng, Kimmie
Bullock, Andrea
Genkinger, Jeanine
Yip-Schneider, Michele T.
Maitra, Anirban
Wolpin, Brian M.
Hanash, Samir
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2021-03
Volume: 160
Issue: 4
Pages: 1373-1383.e6
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2020.11.052
PMC: PMC8783758
OpenAlex: W3110895646
Cited by: 208
References: 56
Citations by year: 2026: 37 · 2025: 52 · 2024: 40 · 2023: 37 · 2022: 30 · 2021: 12
FWCI: 7.13
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Gastroenterology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
IUScholarWorks (Indiana University) (submittedVersion)
Purdue University Indianapolis (Indiana University) (submittedVersion)
Funders: National Institutes of Health
National Cancer Institute
Pancreatic Cancer Action Network
Lustgarten Foundation
University of Texas MD Anderson Cancer Center
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Keywords: CA19-9, pancreatic cancer, early detection, liquid biopsy, circulating tumor markers, TIMP-1, LRG1, multimarker panels, pre-diagnostic biomarkers, chronic pancreatitis, pancreatic cysts, PLCO Cancer Screening Trial
MeSH terms: Liquid Biopsy, Aged, Diagnosis, Differential, Feasibility Studies, Female, Humans, Male, Mass Screening, Middle Aged, Pancreatic Cyst, Pancreatic Neoplasms, Sensitivity and Specificity, United States, CA-19-9 Antigen, Pancreatitis, Chronic, Early Detection of Cancer, Healthy Volunteers

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