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2017-01-01
2021-02-28
2021-02-28
33
NCT03578939
Istituto Clinico Humanitas
Istituto Clinico Humanitas
OBSERVATIONAL
Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-02-19 | N/A | 2021-03-17 |
2018-07-05 | N/A | 2021-03-18 |
2018-07-06 | N/A | 2021-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis, | 18 Months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
