Advancing the Clinical Translation of Cyst Fluid Assays for Early Detection of Pancreatic Cancer
推进囊肿液检测的临床转化以早期检测胰腺癌
基本信息
- 批准号:10639705
- 负责人:
- 金额:$ 35.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-05-16 至 2028-04-30
- 项目状态:未结题
- 来源:
- 关键词:AdenocarcinomaAmylasesAspartic EndopeptidasesAttentionBiochemicalBiologicalBiological AssayBloodCarcinoembryonic AntigenCellsCellularityClinicalCollaborationsCollectionCystCyst FluidCytologyDataDiagnosisDiagnosticDiagnostic testsDysplasiaEarly DiagnosisEpithelial CellsEvaluationExcisionFluorescenceFreezingGastroenterologyGlucoseHealth Care CostsHigh grade dysplasiaIndustryInterventionLiquid substanceMalignant - descriptorMalignant neoplasm of pancreasMass Spectrum AnalysisMorbidity - disease rateMucinousMucinsMucous body substanceNeedlesNeoplasmsOperative Surgical ProceduresPancreatic AdenocarcinomaPancreatic CystPancreatic cystic neoplasiaPathologyPathway interactionsPatientsPeptide HydrolasesPerformancePharmaceutical ChemistryProceduresProtocols documentationPublishingReaderReproducibilityRunningSamplingSerine ProteaseSerumSiteStandardizationStomachTechnologyTemperatureTestingUnited StatesViscosityWarm Ischemiaaspirateclinical biomarkersclinical decision-makingclinical practiceclinical translationdetection assaydetection limitdiagnostic accuracygastricsinimprovedmortality riskneoplasticnovelovertreatmentprospectiveradiological imagingrisk stratificationsample collectionstandard of caretooltripeptidyl aminopeptidase
项目摘要
PROJECT SUMMARY
Pancreatic cystic lesions (PCLs) represent an opportunity for early detection of pancreatic adenocarcinoma.
The accurate identification of cysts with high grade dysplasia or invasive adenocarcinoma, together referred to
as “Advanced Neoplasia” (AN), that warrant surgical intervention represents a critical unmet need in the
management of PCLs. Most pancreatic cysts with the potential to develop AN are mucinous; in contrast, non-
mucinous PCLs have little or no malignant potential. Biochemical and cytological analysis of aspirated cyst
fluid are important tools in the diagnosis and risk stratification of PCLs. However, sensitivity of the only clinical
biomarker for mucinous cysts, carcinoembryonic antigen (CEA), is insufficient to allow clinicians to confidently
remove patients from surgical consideration. Moreover, the most commonly performed CEA assay requires
500 L of fluid, which is often unavailable. For over 50% of patients that undergo invasive trans-gastric cyst
fluid aspiration, inadequate biospecimen is obtained to run the standard of care biochemical tests. In an effort
to improve the sensitivity and applicability of cyst fluid analysis, we used our novel multiplex mass
spectrometry technology to identify the protease gastricsin which accurately identifies mucinous cysts with an
AUC of 0.98 and requires only 5 L fluid. Despite reliance by clinicians on these analyses to guide clinical
decision-making, little effort has been directed toward optimization of biospecimen processing for pancreatic
cyst fluid. There are no standardized pathways for cyst fluid processing and, unlike other biospecimens such
as serum, pancreatic cyst fluid has variable viscosity and contamination with blood and proteinaceous material
that could interfere with assay reproducibility. It is unknown if the variability we observe clinically in cyst fluid
CEA and cytology reflects true biological differences or inconsistent preanalytical biospecimen processing. The
overall objective of this proposal is to improve completeness, reproducibility, and accuracy in
pancreatic cyst fluid diagnostic evaluation in order to improve the early diagnosis of pancreatic cancer
while avoiding the burdens of overdiagnosis and overtreatment. To achieve our objective, we will
systematically evaluate the impact of preanalytical variables on cyst fluid biochemical and cytological analysis
(Aim 1) and identify strategies to mitigate the small volumes of available cyst fluid (Aim 2) in order to develop
a streamlined, reproducible protocol (Aim 3) that improves the reliable early detection of pancreatic cancer.
We will then validate the performance of our streamlined protocol using prospectively - collected clinical
samples, and we will evaluate inter-assay variability by implementing the protocols at two independent sites.
By improving the reliability of our assays, clinicians will be able to direct surgical intervention appropriately to
patients with incipient pancreatic cancer while sparing others unnecessary risks of mortality, substantial
morbidity, and health care costs.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kimberly Saunders Kirkwood其他文献
Neoadjuvant Therapy Decreases Postoperative Pancreatic Fistula, Delayed Gastric Emptying, and Systemic Morbidity in Patients Undergoing Pancreaticoduodenectomy: An American College of Surgeons NSQIP Analysis
- DOI:
10.1016/j.jamcollsurg.2020.07.529 - 发表时间:
2020-10-01 - 期刊:
- 影响因子:
- 作者:
Alexa Glencer;Jeremy Sharib;Paige Bracci;Tyler J. York;Sophia Hernandez;Kimberly Saunders Kirkwood;Carlos Uriel Corvera - 通讯作者:
Carlos Uriel Corvera
Minimally Invasive Splenectomy Is Associated with Decreased Serious Complications: A 2008-2018 NSQIP Analysis
- DOI:
10.1016/j.jamcollsurg.2020.07.195 - 发表时间:
2020-10-01 - 期刊:
- 影响因子:
- 作者:
Sophia Hernandez;Tyler J. York;Alexa Glencer;Jeremy Sharib;James Ross;Alexander Sehyun Kim;Paige Bracci;Kimberly Saunders Kirkwood - 通讯作者:
Kimberly Saunders Kirkwood
Kimberly Saunders Kirkwood的其他文献
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{{ truncateString('Kimberly Saunders Kirkwood', 18)}}的其他基金
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