NCT03578939: LAPC-NGS-A/001

Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

Completed Last updated 18 March 2021

What this trial tests

trial testing Biopsy EUS guided in Adenocarcinoma in 33 participants. Completed in 28 February 2021.

Timeline

1 January 2017

Primary endpoint
28 February 2021

28 February 2021

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Status	Completed
Study type	OBSERVATIONAL
Enrollment	33
Start date	1 January 2017
Primary completion	28 February 2021
Estimated completion	28 February 2021
Sites	1 location across Italy

Drugs / interventions tested

• Biopsy EUS guided

Conditions studied

• Adenocarcinoma — all drugs for Adenocarcinoma →

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Side-by-side comparison of next-generation sequencing, cytology, and histology in diagnosing locally advanced pancreatic adenocarcinoma.
   Carrara S, Soldà G, Di Leo M, Rahal D, et al · · 2021 · cited 25× · PMID 32640200 · DOI 10.1016/j.gie.2020.06.069