Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

Adenocarcinoma Clinical Trial

— LAPC-NGS-A/001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578939
• Other study ID #: 1890
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma

Intervention

Procedure:
• Biopsy EUS guided
NGS Sequencing on Biopsy samples

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,		18 Months