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OpenTrials
Completed

NCT Number: NCT03578939

Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Biopsy EUS guided

Procedure

NGS Sequencing on Biopsy samples

Primary outcomes

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

    Time frame: 18 Months

Secondary outcomes

  1. Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,

    Time frame: 18 Months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: LAPC-NGS-A/001

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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