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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06519500
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regina Elena Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laura Monteonofrio, Doctor
Principal Investigator Affiliation IRCCS "Regina Elena" National Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gastro-entero-pancreatic Neoplasms
Additional Details

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

Arms & Interventions

Arms

: 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).

Interventions

Contact a Trial Team

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International Sites

"Regina Elena" National Cancer Institute, Rome, Italy

Status

Recruiting

Address

"Regina Elena" National Cancer Institute

Rome, , 00144

Site Contact

Laura Monteonofrio, Doctor

[email protected]

0652665270 #+39

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