Lead-time trajectory of CA19-9 as an anchor marker for pancreatic cancer early detection
Open accessAbstract
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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CA19-9 elevations can be observed in plasma samples obtained before diagnosis, suggesting a potential window for early detection.
“CA19–9 elevations can be observed in plasma samples obtained in the pre-diagnostic setting, suggesting a potential window of opportunity for early detection38.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [38]
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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)
- 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
- 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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