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

July 19, 2024 updated by: Regina Elena Cancer Institute
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

40

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

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Recruiting
        • "Regina Elena" National Cancer Institute
        • Contact:
          • Laura Monteonofrio, Doctor
          • Phone Number: +39 0652665270

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients affected by GEP-NEN undergoing treatment will be enrolled in this study surgery to remove the tumor

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • previous chemotherapy treatments

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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-pancreatic neoplasms (GEP-NEN).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Set up of at least 10 organoid cultures
Time Frame: 42 months
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

Collaborators and Investigators

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

Sponsor

Regina Elena Cancer Institute

Investigators

  • Principal Investigator: Laura Monteonofrio, Doctor, IRCCS "Regina Elena" National Cancer Institute

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 Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Estimated)

March 3, 2026

Study Completion (Estimated)

November 3, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1823/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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