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临床试验/NCT04246710
NCT04246710进行中(未招募)不适用

Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
160
试验地点
1
主要终点
Feasibility of PDAC molecular subtyping on biopsy samples

研究概览

简要总结

This study evaluated the feasibility and reliability of PDAC molecular subtyping on tissue core biopsies samples acquired under EUS guidance. Moreover, this study will assess the impact of molecular subtypes assessed on EUS-FNB samples in patients with resectable and unresectable (locally advanced, advanced, and metastatic) PDAC undergoing chemotherapy on treatment response and survival and the utility in monitoring disease response to therapy and early occurrence of disease relapse using the TaqMan RNA assay in serum

详细描述

PDAC patients are categorised as resectable, borderline resectable, locally advanced, metastatic and recurrent. Substantial neoplastic tissue is only available for the resectable group. This is unfortunate as the other groups are those that would benefit the most from molecular characterization and identification of markers, which may be predictive and/or provide therapeutic stratification. For these categories of patients, only fine needle aspiration or small biopsies could be obtained until now. However, the introduction of new needles, specifically designed to acquire larger high quality biopsy samples under endoscopic ultrasound (EUS), has now made it possible to test prognostic, predictive and therapeutic stratification markers. However, the applicability of EUS-fine needle biopsy (EUS-FNB) samples for this purpose has yet to be clinically validated. The working hypothesis of this proposal is that the molecular sub-classification of PDAC on EUS-FNB tissue samples could be applied for prognostic stratification and therapeutic decision strategies in both resectable and unresectable patients using DNA and RNA biomarkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to EUS with FNB in the suspect of pancreatic cancer
  • Availability of biopsies obtained during EUS-FNB
  • Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
  • Age >18 and <80 years
  • Willing to be followed up at the Fondazione Policlinico A. Gemelli University Hospital
  • Able to sign informed consent

排除标准

  • Histological diagnoses other than pancreatic ductal adenocarcinoma
  • Pregnancy or lactation
  • Unable to sigh informed consent

结局指标

主要结局

Feasibility of PDAC molecular subtyping on biopsy samples

时间窗: At 6 months

Number of patients in whom molecular subtyping on biopsy samples is obtained

Reliability of PDAC molecular subtyping on biopsy samples

时间窗: At 1 year

concordance between molecular subtyping on biopsy samples and surgery specimens

次要结局

  • Overall survival(From date of enrollment assessed until death or up to 3 years)
  • Progression-free-survival (PFS)(From date of enrollment assessed until death or up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guido Costamagna

Professor

Catholic University of the Sacred Heart

研究点 (1)

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