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Recruiting

NCT Number: NCT06519500

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

Location contact

Laura Monteonofrio, Doctor

CONTACT

0652665270 ext. +39

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Laura Monteonofrio, Doctor

CONTACT

[email protected]

0652665270 ext. +39

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.