Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples
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
- 否
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
Guido Costamagna
Professor
Catholic University of the Sacred Heart
