A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
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The National Cancer Institute and the National Institute for Diabetes and Digestive and Kidney Diseases initiated the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) in 2015 (the CPDPC's origin, structure, governance, and research objectives are described in another article in this journal). One of the key objectives of CPDPC is to assemble a cohort of 10,000 subjects 50 years or older with new-onset diabetes, called the NOD cohort. Using a define, enrich, and find early detection approach, the aims of the NOD study are to ( a ) estimate the 3-year probability of pancreatic ductal adenocarcinoma (PDAC) in NOD ( define ), (b) establish a biobank of clinically annotated biospecimens from presymptomatic PDAC and control new-onset type 2 diabetes mellitus subjects, (c) conduct phase 3 validation studies of promising biomarkers for identification of incident PDAC in NOD patients ( enrich ), and (d) provide a platform for development of a future interventional screening protocol for early detection of PDAC in patients with NOD that incorporates imaging studies and/or clinical algorithms ( find ). It is expected that 85 to 100 incidences of PDAC will be diagnosed during the study period in this cohort of 10,000 patients.
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The currently used blood-based biomarker, CA 19-9, accurately predicts only 65% of those with early disease when surgical treatment is a viable option.
“and the currently used blood-based biomarker, CA 19-9, accurately predicts only 65% of those with early disease when surgical treatment is a viable option.3,167”
From Artificial Intelligence and Early Detection of Pancreatic Cancer: 2020 Summative Review (2021) · cites this paper as [167]
The Biomarkers for Early Detection of PDAC section identifies CA 19-9 as a leading biomarker and says its sensitivity for asymptomatic PDAC is low. It does not report 65% sensitivity in surgically treatable early disease; instead, it assumes 50% sensitivity for study planning in the new-onset diabetes population. The Background and Significance section separately explains why detection while cancer is resectable matters. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSurgery is the only therapy to date associated with a durable long-term outcome.
“This result is based on the findings that surgery is the only therapy to date associated with a durable long-term outcome.”
From Artificial Intelligence and Early Detection of Pancreatic Cancer: 2020 Summative Review (2021) · cites this paper as [167]
The Background and Significance section says that detecting pancreatic cancer while it is still resectable permits therapeutic options that result in long-term survival. It does not say surgery is the only such therapy or establish that the outcome is durable. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSeveral studies have shown that early detection of PDAC improves outcome.
“Several studies have shown that early detection of PDAC improves outcome.”
From Artificial Intelligence and Early Detection of Pancreatic Cancer: 2020 Summative Review (2021) · cites this paper as [167]
The Background and Significance section says detecting PDAC while it is resectable could permit treatment leading to long-term survival. The Biomarkers for Early Detection of PDAC section describes improved survival as an anticipated benefit, not an outcome that several studies have shown. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe US Consortium on Chronic Pancreatitis, Diabetes, and Pancreatic Cancer has initiated a longitudinal cohort study, the New-Onset Hyperglycemia and Diabetes Cohort, to discover and validate high-sensitive and specificity biomarkers to identify patients with a high probability of having early PDAC.
“In a major effort to developing tests (liquid biopsy and imaging), the US Consortium on Chronic Pancreatitis, Diabetes, and Pancreatic Cancer has initiated a longitudinal cohort study, the New-Onset Hyperglycemia and Diabetes Cohort, to discover and validate high-sensitive and specificity biomarkers to identify patients with a high probability of having early PDAC.167”
From Artificial Intelligence and Early Detection of Pancreatic Cancer: 2020 Summative Review (2021) · cites this paper as [167]
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Experimental — accuracy not yet measuredThe size of the lesion at the time of surgery is a predictor of long-term survival.
“Furthermore, the size of the lesion at the time of surgery is a predictor of long-term survival.3,166,167”
From Artificial Intelligence and Early Detection of Pancreatic Cancer: 2020 Summative Review (2021) · cites this paper as [167]
The Background and Significance section says that detecting pancreatic cancer while it is resectable can permit treatments leading to long-term survival. It does not address whether lesion size at surgery predicts survival; searches for lesion size, surgical resection, and prognosis found no such passage. Page numbers were unavailable in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
Studies underway in the USA and UK are actively investigating how best to detect pancreatic ductal adenocarcinoma in individuals with new-onset diabetes.
“However, studies underway in the USA61 and UK62 are actively investigating how best to detect pancreatic ductal adenocarcinoma in individuals with new-onset diabetes.”
From Early detection of pancreatic cancer (2020) · cites this paper as [61]
The predicted incidence of pancreatic ductal adenocarcinoma among people with new-onset diabetes after age 50 is only 1-2% over 3 years.
“although the incidence of pancreatic ductal adenocarcinoma in this group is predicted to be only 1–2% over a 3-year period.”
From Early detection of pancreatic cancer (2020) · cites this paper as [61]
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Self-citation
- Authors
- Maitra, A., Sharma, A., Brand, R. E., Van Den Eeden, S. K., Fisher, W. E., Hart, P. A., Hughes, S. J., Mather, K. J., Pandol, S. J., Park, W. G., Feng, Z., Serrano, J., Rinaudo, J. A. S., Srivastava, S., & Chari, S. T.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Mayo Clinic (US)
- University of Pittsburgh Medical Center (US)
- Division of Research, Kaiser Permanente Northern California, Oakland, CA;
- Baylor College of Medicine (US)
- The Ohio State University Wexner Medical Center (US)
- University of Florida Health (US)
- Indiana University Indianapolis (US)
- Cedars-Sinai Medical Center (US)
- Stanford Medicine (US)
- Fred Hutch Cancer Center (US)
- Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; and
- National Cancer Institute (US)
- Corresponding author
- Maitra, Anirban
- Mather, Kieren J.
- ORCID
- Venue
- Pancreas
- Published
- 2018-11
- Volume
- 47
- Issue
- 10
- Pages
- 1244-1248
- ISSN
- 0885-3177 (ISSN-L)
- 1536-4828
- PMC
- PMC6432934
- OpenAlex
- W2896405398
- Cited by
- 93
- References
- 16
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 6 · 2023: 8 · 2022: 12 · 2021: 23 · 2020: 13 · 2019: 6 · 2018: 3
- FWCI
- 4.23
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Pancreas (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Funders
- National Cancer Institute (P01CA163200)
- National Institute of Diabetes and Digestive and Kidney Diseases (U01DK108327, U01DK108326, U01DK108320, U01DK108332, L30 DK118657, U01DK108300, U01DK108306, U01DK108323, U01DK108314, U01DK108328, U01DK108288, P01DK098108)
- Topics
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
- Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
- Keywords
- pancreatic ductal adenocarcinoma, early cancer detection, pancreatic cancer screening, chronic pancreatitis, biomarkers, biobanks, pancreatic cancer incidence
- MeSH terms
- Blood Specimen Collection, Diabetes Mellitus, Type 2, Humans, Middle Aged, Pancreatic Neoplasms, Prospective Studies, Research Design, Carcinoma, Pancreatic Ductal, Biomedical Research, Early Diagnosis, Pancreatitis, Chronic, Young Adult
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