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Clinical Trials/NCT06519500
NCT06519500
Recruiting
Not Applicable

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

Regina Elena Cancer Institute1 site in 1 country40 target enrollmentMarch 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastro-entero-pancreatic Neoplasms
Sponsor
Regina Elena Cancer Institute
Enrollment
40
Locations
1
Primary Endpoint
Set up of at least 10 organoid cultures
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
March 3, 2023
End Date
November 3, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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