Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours

NCT06121622 | Recruiting

• 1 other identifier: 3DPanNET
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is to generate new personalised 3D preclinical models of pancreatic neuroendocrine tumors. The models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing. For the development of the newly proposed models, patients' surgical specimens will be evaluated by the Pathological Unit. If the presence of pathological material in excess, not required for the routine diagnostic procedure, is confirmed, such material will be employed for the generation of the proposed personalised models.

Conditions

Pancreatic Neuroendocrine Tumor

Keywords

PanNET; 3D preclinical models

Outcome Measures

Primary Outcomes (1)

• Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours

  Generation of new 3D preclinical models of pancreatic neuroendocrine tumors for the study of the disease biology and for the assessment of drug response

  from the day of surgery until 3 years from surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total number of approximately 70 patients will be enrolled

You may qualify if:

• patients who undergo pancreatic surgical resection for non-functioning pancreatic neuroendocrine tumor
• age ≥ 18 years
• informed consent

You may not qualify if:

• non-pancreatic neuroendocrine tumor histological diagnosis
• age \< 18 years

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffele Institute

Milan, MI, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour surgical samples not required for diagnostic procedures, will be employed for the generation of personalised 3D preclinical models

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Massimo Falconi, Professor

CONTACT

0039 022643 6046; falconi.massimo@hsr.it

Anna Battistella, MD

CONTACT

0039 02 26433484; battistella.anna1@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (1)