Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

NCT03578939 | Completed

• 1 other identifier: 1890
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,

  18 Months

Interventions

Biopsy EUS guided PROCEDURE

NGS Sequencing on Biopsy samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with non-primary pancreatic tumors, pancreatic neuroendocrine tumors or benign pancreatic masses
• Patients who have already undergone cancer treatment of any kind

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 32640200 DERIVED

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Silvia Carrara, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: July 6, 2018
• Study Start: January 1, 2017
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)