Suppr超能文献

胰腺癌的早期检测:生物标志物发现及早期验证研究中的研究设计与分析考量

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

作者信息

Smith Lynette M, Mahoney Douglas W, Bamlet William R, Yu Fang, Liu Suyu, Goggins Michael G, Darabi Sourat, Majumder Shounak, Wang Qiao-Li, Coté Gregory A, Demeure Michael J, Zhang Zhen, Srivastava Sudhir, Chawla Akhil, Izmirlian Grant, Olson Janet E, Wolpin Brian M, Genkinger Jeanine M, Zaret Kenneth S, Brand Randall, Koay Eugene J, Oberg Ann L

机构信息

Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, USA.

Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.

出版信息

Pancreatology. 2024 Dec;24(8):1265-1279. doi: 10.1016/j.pan.2024.10.012. Epub 2024 Oct 29.

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 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.

摘要

目的

胰腺导管腺癌(PDAC)是一种致死率很高的疾病,早期检测具有挑战性。需要能够在疾病进程早期检测出PDAC的生物标志物,此时进行干预可带来最佳治疗效果。我们重点介绍有助于胰腺癌早期检测生物标志物评估的研究设计和统计学考量因素。

方法

我们描述了在此背景下的实验设计策略,这些策略有助于在生物标志物开发的每个早期检测研究网络(EDRN)阶段简化生物标志物评估。我们将EDRN早期阶段细分为子阶段,提出目标、研究设计策略和生物标志物性能基准。

结果

描述了在PDAC高危人群中进行早期检测的目标。在无疾病的受监测患者中评估生物标志物行为可以筛选出候选生物标志物。介绍了生物标志物验证研究的潜在资源。

结论

多中心和多学科合作可以促进针对这种致死率高但发病率低的疾病的研究设计策略,并简化从生物标志物发现到临床应用的流程。分析和实验设计方法的改进有助于在生物标志物开发阶段加速生物标志物评估。

相似文献

2
4
Can a Liquid Biopsy Detect Circulating Tumor DNA With Low-passage Whole-genome Sequencing in Patients With a Sarcoma? A Pilot Evaluation.
Clin Orthop Relat Res. 2025 Jan 1;483(1):39-48. doi: 10.1097/CORR.0000000000003161. Epub 2024 Jun 21.
5
Early detection of pancreatic cancer by a high-throughput protease-activated nanosensor assay.
Sci Transl Med. 2025 Feb 12;17(785):eadq3110. doi: 10.1126/scitranslmed.adq3110.
6
Early Detection of Pancreatic Cancer: Opportunities and Challenges.
Gastroenterology. 2019 May;156(7):2024-2040. doi: 10.1053/j.gastro.2019.01.259. Epub 2019 Feb 2.
7
Identification and verification of transthyretin as a potential biomarker for pancreatic ductal adenocarcinoma.
J Cancer Res Clin Oncol. 2013 Jul;139(7):1117-27. doi: 10.1007/s00432-013-1422-4. Epub 2013 Apr 2.
8
Methylated DNA in Pancreatic Juice Distinguishes Patients With Pancreatic Cancer From Controls.
Clin Gastroenterol Hepatol. 2020 Mar;18(3):676-683.e3. doi: 10.1016/j.cgh.2019.07.017. Epub 2019 Jul 16.
10
Use of endoanal ultrasound for reducing the risk of complications related to anal sphincter injury after vaginal birth.
Cochrane Database Syst Rev. 2015 Oct 29;2015(10):CD010826. doi: 10.1002/14651858.CD010826.pub2.

本文引用的文献

1
Considerations for using potential surrogate endpoints in cancer screening trials.
Lancet Oncol. 2024 May;25(5):e183-e192. doi: 10.1016/S1470-2045(24)00015-9.
2
Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening.
N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336.
3
4
Cancer Diagnoses After Recent Weight Loss.
JAMA. 2024 Jan 23;331(4):318-328. doi: 10.1001/jama.2023.25869.
5
Next-generation Multi-target Stool DNA Panel Accurately Detects Colorectal Cancer and Advanced Precancerous Lesions.
Cancer Prev Res (Phila). 2024 Mar 4;17(3):119-126. doi: 10.1158/1940-6207.CAPR-23-0285.
6
International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas.
Pancreatology. 2024 Mar;24(2):255-270. doi: 10.1016/j.pan.2023.12.009. Epub 2023 Dec 28.
7
Large-scale pancreatic cancer detection via non-contrast CT and deep learning.
Nat Med. 2023 Dec;29(12):3033-3043. doi: 10.1038/s41591-023-02640-w. Epub 2023 Nov 20.
9
Plasma Methylated DNA Markers for Melanoma Surveillance.
JCO Precis Oncol. 2023 Sep;7:e2300389. doi: 10.1200/PO.23.00389.
10
Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study.
Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验