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Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03578939
Acronym
LAPC-NGS-A/001
Enrollment
33
Registered
2018-07-06
Start date
2017-01-01
Completion date
2021-02-28
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma

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.

Interventions

PROCEDUREBiopsy EUS guided

NGS Sequencing on Biopsy samples

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,18 Months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026