Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

Completed

• Conditions: Adenocarcinoma

• Registration Number: NCT03578939
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-06
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.	18 Months

Secondary Outcome Measures

Name	Time	Method
Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,	18 Months

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy