Clinical trial NCT03578939: Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma
Official title: Next Generation Sequencing di Cellule Tumorali Nell'Adenocarcinoma Pancreatico Localmente Avanzato
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients belonging 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.

At the time of preparation for the examination, patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells.

Patients will then be subjected to the endoscopic procedure (EUS with biopsy) provided for by good clinical practice in consideration of the suspected diagnosis for which they come to our attention.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.
timeFrame: 18 Months
Secondary outcomes:
measure: Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,
timeFrame: 18 Months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Silvia Carrara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrara S, Solda G, Di Leo M, Rahal D, Peano C, Giunta M, Lamonaca L, Auriemma F, Anderloni A, Fugazza A, Maselli R, Malesci A, Laghi L, Repici A. Side-by-side comparison of next-generation sequencing, cytology, and histology in diagnosing locally advanced pancreatic adenocarcinoma. Gastrointest Endosc. 2021 Mar;93(3):597-604.e5. doi: 10.1016/j.gie.2020.06.069. Epub 2020 Jul 5.