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Early detection of pancreatic cancer : Study design and analytical considerations in biomarker discovery and early phase validation studies

Smith, Lynette M ; Mahoney, Douglas W ; Bamlet, William R ; Yu, Fang ; Liu, Suyu ; Goggins, Michael G ; Darabi, Sourat ; Majumder, Shounak ; Wang, Qiao-Li LU orcid and Coté, Gregory A , et al. (2024) In Pancreatology 24(8). p.1265-1279
Abstract

OBJECTIVES: Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that is challenging to detect at an early stage. Biomarkers are needed that can detect PDAC early in the course of disease when interventions lead to the best outcomes. We highlight study design and statistical considerations that inform pancreatic cancer early detection biomarker evaluation.

METHODS: We describe experimental design strategies in this setting useful for streamlining biomarker evaluation at each Early Detection Research Network (EDRN) phase of biomarker development. We break the early EDRN phases into sub-phases, proposing objectives, study design strategies, and biomarker performance benchmarks.

RESULTS: The goal of early... (More)

OBJECTIVES: Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that is challenging to detect at an early stage. Biomarkers are needed that can detect PDAC early in the course of disease when interventions lead to the best outcomes. We highlight study design and statistical considerations that inform pancreatic cancer early detection biomarker evaluation.

METHODS: We describe experimental design strategies in this setting useful for streamlining biomarker evaluation at each Early Detection Research Network (EDRN) phase of biomarker development. We break the early EDRN phases into sub-phases, proposing objectives, study design strategies, and biomarker performance benchmarks.

RESULTS: The goal of early detection in populations at high-risk of PDAC is described. Evaluating biomarker behavior in patients under surveillance without disease can winnow candidate biomarkers. Potential resources for biomarker validation studies are described.

CONCLUSIONS: Multisite and multidisciplinary collaboration can facilitate study design strategies in this lethal but low incidence disease and streamline the path from biomarker discovery to clinical use. Improvements in analytical and experimental design methods could help accelerate biomarker evaluation through the phases of biomarker development.

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publishing date
type
Contribution to journal
publication status
published
keywords
Humans, Pancreatic Neoplasms/diagnosis, Biomarkers, Tumor, Early Detection of Cancer/methods, Carcinoma, Pancreatic Ductal/diagnosis, Research Design
in
Pancreatology
volume
24
issue
8
pages
1265 - 1279
publisher
Elsevier
external identifiers
  • scopus:85208483083
  • pmid:39516175
ISSN
1424-3903
DOI
10.1016/j.pan.2024.10.012
language
English
LU publication?
no
additional info
Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.
id
9e8b7355-f074-4a0d-a54f-5e563488de9e
date added to LUP
2025-05-12 17:18:54
date last changed
2025-07-08 09:55:20
@article{9e8b7355-f074-4a0d-a54f-5e563488de9e,
  abstract     = {{<p>OBJECTIVES: Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that is challenging to detect at an early stage. Biomarkers are needed that can detect PDAC early in the course of disease when interventions lead to the best outcomes. We highlight study design and statistical considerations that inform pancreatic cancer early detection biomarker evaluation.</p><p>METHODS: We describe experimental design strategies in this setting useful for streamlining biomarker evaluation at each Early Detection Research Network (EDRN) phase of biomarker development. We break the early EDRN phases into sub-phases, proposing objectives, study design strategies, and biomarker performance benchmarks.</p><p>RESULTS: The goal of early detection in populations at high-risk of PDAC is described. Evaluating biomarker behavior in patients under surveillance without disease can winnow candidate biomarkers. Potential resources for biomarker validation studies are described.</p><p>CONCLUSIONS: Multisite and multidisciplinary collaboration can facilitate study design strategies in this lethal but low incidence disease and streamline the path from biomarker discovery to clinical use. Improvements in analytical and experimental design methods could help accelerate biomarker evaluation through the phases of biomarker development.</p>}},
  author       = {{Smith, Lynette M and Mahoney, Douglas W and Bamlet, William R and Yu, Fang and Liu, Suyu and Goggins, Michael G and Darabi, Sourat and Majumder, Shounak and Wang, Qiao-Li and Coté, Gregory A and Demeure, Michael J and Zhang, Zhen and Srivastava, Sudhir and Chawla, Akhil and Izmirlian, Grant and Olson, Janet E and Wolpin, Brian M and Genkinger, Jeanine M and Zaret, Kenneth S and Brand, Randall and Koay, Eugene J and Oberg, Ann L}},
  issn         = {{1424-3903}},
  keywords     = {{Humans; Pancreatic Neoplasms/diagnosis; Biomarkers, Tumor; Early Detection of Cancer/methods; Carcinoma, Pancreatic Ductal/diagnosis; Research Design}},
  language     = {{eng}},
  number       = {{8}},
  pages        = {{1265--1279}},
  publisher    = {{Elsevier}},
  series       = {{Pancreatology}},
  title        = {{Early detection of pancreatic cancer : Study design and analytical considerations in biomarker discovery and early phase validation studies}},
  url          = {{http://dx.doi.org/10.1016/j.pan.2024.10.012}},
  doi          = {{10.1016/j.pan.2024.10.012}},
  volume       = {{24}},
  year         = {{2024}},
}