Generation Of Organoids Of Neuroendocrine Neoplasms Of The Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery

Study Overview

Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery

Observational, prospective, feasibility pilot study of the preparation of organoids starting from tumor tissue and surrounding healthy tissue, collected during surgery, performed according to standard clinical practice.

Given the need for the use of experimental models that mimic the tumor of origin

Gastro-entero-pancreatic Neoplasms

RS1823/23

Study Record Dates

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
First Submitted 2024-07-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-19
First Submitted that Met QC Criteria 2024-07-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-25
First Posted (ACTUAL) 2024-07-25	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Patients undergoing surgery for neuroendocrine neoplasia At least 10 cultures of organoids of Gastro-entero-pancreatic neoplasms (GEP-NEN) derived from patients undergoing surgery for neuroendocrine neoplasia. This study will allow us to define the success rate in the generation of organoids from gastro-entero-

Primary Outcome Measures	Measure Description	Time Frame
Set up of at least 10 organoid cultures	The organoids will be generated from tumor tissue samples and surrounding healthy tissue obtained from patients affected by GEP-NEN (who meet the inclusion/exclusion criteria) collected, according to clinical practice, during tumor resection surgery. Only the excess material after carrying out all the investigations necessary for the correct diagnosis histological analysis can be used for the purpose of the project	42 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Laura Monteonofrio, Doctor

Phone Number: 0652665270

Email: laura.monteonofrio@ifo.it

Participation Criteria

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:

over 18 years of age;
diagnosis of GEP-NEN carried out via histological investigation or via positivity to the uptake PET-CT with 68Ga-peptides;
availability of adequate material for the preparation of organoid cultures, derived from surgery;
written informed consent.

previous chemotherapy treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Laura Monteonofrio, Doctor, IRCCS "Regina Elena" National Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record