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Abstract：
BACKGROUND: Pancreatic cancer, predominantly characterized by ductal adenocarcinoma (PDAC) accounts for 90% of cases and is the fourth leading cause of cancer-related deaths globally. Its incidence is notably increasing. This poor prognosis is primarily due to late-stage diagnosis (approximately 70% to 80% of patients are diagnosed at an advanced stage), aggressive tumor biology, and low sensitivity to chemotherapy. Consequently, it is crucial to identify and develop a simple, feasible and reproducible blood-based signature (i.e., combination of biomarkers) for early detection of PDAC.
METHODS: The PANLIPSY study is a multi-center, non-interventional prospective clinical trial designed to achieve early detection of PDAC with high specificity and sensitivity, using a combinatorial approach in blood samples. These samples are collected from patients with resectable, borderline or locally advanced, and metastatic stage PDAC within the framework of the French Biological and Clinical Database for PDAC cohort (BACAP 2). All partners of the BACAP consortium are eligible to participate. The study will include 215 PDAC patients, plus 25 patients with benign pancreatic conditions from the PAncreatic Disease Cohort of TOuLouse (PACTOL) cohort, and 115 healthy controls, totaling 355 individuals. Circulating biomarkers will be collected in a total volume of 50 mL of blood, divided into one CellSave tube (10 mL), two CELL-FREE DNA BCT® preservative tubes (18 mL), and five EDTA tubes (22 mL in total). Samples preparation will adhere to the guidelines of the European Liquid Biopsy Society (ELBS). A unique feature of the study is the AI-based comparison of these complementary liquid biopsy biomarkers. Main end-points: i) to define a liquid biopsy signature that includes the most relevant circulating biomarkers, ii) to validate the multi-marker panel in an independent cohort of healthy controls and patients, with resectable PDAC, and iii) to establish a unique liquid biopsy biobank for PDAC study.
CONCLUSIONS: The PANLIPSY study is a unique prospective non-interventional clinical trial that brings together liquid biopsy experts. The aim is to develop a biological signature for the early detection of PDAC based on AI-assisted detection of circulating biomarkers in blood samples (CTCs, ctDNA, EVs, circulating immune system, circulating cell-free nucleosomes, proteins, and microbiota).
BACKGROUND: ClinicalTrials.gov Identifier: NCT06128343 / NCT05824403. Registration dates: June 8,2023 and April 21, 2023.
METHODS: The PANLIPSY study is a multi-center, non-interventional prospective clinical trial designed to achieve early detection of PDAC with high specificity and sensitivity, using a combinatorial approach in blood samples. These samples are collected from patients with resectable, borderline or locally advanced, and metastatic stage PDAC within the framework of the French Biological and Clinical Database for PDAC cohort (BACAP 2). All partners of the BACAP consortium are eligible to participate. The study will include 215 PDAC patients, plus 25 patients with benign pancreatic conditions from the PAncreatic Disease Cohort of TOuLouse (PACTOL) cohort, and 115 healthy controls, totaling 355 individuals. Circulating biomarkers will be collected in a total volume of 50 mL of blood, divided into one CellSave tube (10 mL), two CELL-FREE DNA BCT® preservative tubes (18 mL), and five EDTA tubes (22 mL in total). Samples preparation will adhere to the guidelines of the European Liquid Biopsy Society (ELBS). A unique feature of the study is the AI-based comparison of these complementary liquid biopsy biomarkers. Main end-points: i) to define a liquid biopsy signature that includes the most relevant circulating biomarkers, ii) to validate the multi-marker panel in an independent cohort of healthy controls and patients, with resectable PDAC, and iii) to establish a unique liquid biopsy biobank for PDAC study.
CONCLUSIONS: The PANLIPSY study is a unique prospective non-interventional clinical trial that brings together liquid biopsy experts. The aim is to develop a biological signature for the early detection of PDAC based on AI-assisted detection of circulating biomarkers in blood samples (CTCs, ctDNA, EVs, circulating immune system, circulating cell-free nucleosomes, proteins, and microbiota).
BACKGROUND: ClinicalTrials.gov Identifier: NCT06128343 / NCT05824403. Registration dates: June 8,2023 and April 21, 2023.
摘要：
背景：胰腺癌，以导管腺癌(PDAC)为主要特征的占病例的90%,是全球癌症相关死亡的第四大原因.其发病率显著增加。这种不良预后主要是由于晚期诊断（大约70％至80％的患者被诊断为晚期）。侵袭性肿瘤生物学，对化疗敏感性低。因此,至关重要的是识别和开发一个简单的，可行和可重复的基于血液的签名(即，生物标志物的组合)用于PDAC的早期检测。
方法：PANLIPSY研究是一个多中心，非干预性前瞻性临床试验旨在实现PDAC的早期检测，具有高特异性和敏感性，在血液样本中使用组合方法。这些样本是从可切除的患者中收集的，边界或本地先进，在法国PDAC队列生物学和临床数据库（BACAP2）的框架内和转移期PDAC。BACAP联盟的所有合作伙伴都有资格参与。该研究将包括215名PDAC患者，加上来自TOuLouse胰腺疾病队列（PACTOL）队列的25例良性胰腺疾病患者，和115个健康对照，共有355人。循环生物标志物将收集在总体积为50mL的血液中，分成一个CellSave管（10mL），两个CELL-FREEDNABCT®防腐管（18毫升），和五个EDTA管(总共22mL)。样品制备将遵守欧洲液体活检学会(ELBS)的指南。该研究的一个独特特征是这些互补液体活检生物标志物的基于AI的比较。主要终点：i）定义包括最相关循环生物标志物的液体活检特征，ii)在健康对照和患者的独立队列中验证多标志物组，使用可切除的PDAC，和iii)建立用于PDAC研究的独特液体活检生物库。
结论：PANLIPSY研究是一项独特的前瞻性非介入临床试验，汇集了液体活检专家。目的是基于AI辅助检测血液样本中的循环生物标志物（CTC，ctDNA,电动汽车,循环免疫系统，循环无细胞核小体，蛋白质，和微生物群)。
背景：ClinicalTrials.gov标识符：NCT06128343/NCT05824403。注册日期：2023年6月8日和2023年4月21日。
方法：PANLIPSY研究是一个多中心，非干预性前瞻性临床试验旨在实现PDAC的早期检测，具有高特异性和敏感性，在血液样本中使用组合方法。这些样本是从可切除的患者中收集的，边界或本地先进，在法国PDAC队列生物学和临床数据库（BACAP2）的框架内和转移期PDAC。BACAP联盟的所有合作伙伴都有资格参与。该研究将包括215名PDAC患者，加上来自TOuLouse胰腺疾病队列（PACTOL）队列的25例良性胰腺疾病患者，和115个健康对照，共有355人。循环生物标志物将收集在总体积为50mL的血液中，分成一个CellSave管（10mL），两个CELL-FREEDNABCT®防腐管（18毫升），和五个EDTA管(总共22mL)。样品制备将遵守欧洲液体活检学会(ELBS)的指南。该研究的一个独特特征是这些互补液体活检生物标志物的基于AI的比较。主要终点：i）定义包括最相关循环生物标志物的液体活检特征，ii)在健康对照和患者的独立队列中验证多标志物组，使用可切除的PDAC，和iii)建立用于PDAC研究的独特液体活检生物库。
结论：PANLIPSY研究是一项独特的前瞻性非介入临床试验，汇集了液体活检专家。目的是基于AI辅助检测血液样本中的循环生物标志物（CTC，ctDNA,电动汽车,循环免疫系统，循环无细胞核小体，蛋白质，和微生物群)。
背景：ClinicalTrials.gov标识符：NCT06128343/NCT05824403。注册日期：2023年6月8日和2023年4月21日。
