Next Generation Sequencing of Tumor Cells in Locally Adva... | NCT03578939

Studies
Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

NCT03578939

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

33Estimated

Phase

Not provided

Conditions

Adenocarcinoma

Interventions

Biopsy EUS guided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Feb 19, 2018

First Submission Date that Met QC Criteria

Jul 5, 2018

First Posted Date

Jul 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2021

Last Update Posted Date

Mar 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Estimated

Name	Type	Description	Arm Group Labels	Other Names
Biopsy EUS guided	Procedure	NGS Sequencing on Biopsy samples

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 Outcomes

Measure	Description	Time Frame
Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,		18 Months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Silvia Carrara, MD	Istituto Clinico Humanitas	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico Humanitas		Rozzano	Milano	20089	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32640200	Derived	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.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms