Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma (LAPC-NGS-A/001)

Istituto Clinico Humanitas

Status: Completed

Conditions: Adenocarcinoma

Treatments: Procedure: Biopsy EUS guided

Study type: Observational

Funder types: Other

Identifiers

NCT03578939

1890

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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