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临床试验/NCT03578939
NCT03578939已完成不适用

Next Generation Sequencing di Cellule Tumorali Nell'Adenocarcinoma Pancreatico Localmente Avanzato

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.

研究概览

简要总结

All patients referring to the U.O .of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma, satisfying all the inclusion criteria and without any of the exclusion criteria, will be enrolled.

Patients will then undergo endoscopic procedures (EUS with biopsy) provided by good clinical practice in consideration of the suspected diagnosis for which they come to Investigator's attention.

Biopsy will be performed using a histology needle (22 G, Acquire, Boston Scientific, MA, United States). The obtained material will be processed in the Pathological Anatomy. A small part of this will be sent to the NGS analysis.

At the time of preparation for the examination, the patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells that will be identified by SmartBioSurface technique (Tethis S.p.A) and analyzed by appropriate molecular markers and NGS.

The clinical evaluation of the patient will take place at 6 months from the date of the procedure, through telephone contact and / or outpatient visit.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 18 years,
  • Signature of informed consent,
  • Naïve patients with pancreatic adenocarcinoma (confirmed cito/ histologically), not subjected to previous treatments,
  • Need to perform EUS with biopsy,
  • Life expectancy over 6 months.

排除标准

  • Patients with non-primary pancreatic tumors, pancreatic neuroendocrine tumors or benign pancreatic masses
  • Patients who have already undergone cancer treatment of any kind

结局指标

主要结局

Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.

时间窗: 18 Months

次要结局

  • Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,(18 Months)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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