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Trial Title:
Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours
NCT ID:
NCT06121622
Condition:
Pancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Conditions: Keywords:
PanNET
3D preclinical models
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
Pancreatic neuroendocrine tumors (PanNETs) are characterized by highly heterogeneous
biological behavior. Another distinctive feature of these neoplasms is the presence of a
dense vascular network, reminiscent of their physiological counterpart. Indeed, the tumor
microenvironment plays a critical role in these neoplasms and influence their therapeutic
management. Although they are typically indolent in nature, approximately 40% of PanNET
patients are metastatic at diagnosis, requiring non-surgical treatments such as
somatostatin therapy, chemotherapy, targeted therapy, and peptide receptor radionuclide
therapy (PRRT). Furthermore, 1 out of 5 patients experience disease recurrence after
surgical resection, necessitating pharmacological therapies. Currently, no specific
recommendations exist on the most effective therapeutic sequence to follow in presence of
metastatic disease/disease relapse. One of the main reasons behind this unmet clinical
need is the scarcity of available preclinical models of these neoplasms able to
accurately reproduce the biology and physiology of the primary tumor and that can be used
as valid platforms for drug testing.
The study aims to generate a new 3D in vitro model of PanNET, replicating the complex
primary tumor in vitro, including also the tumor microenvironment (e.g., vascular network
and stroma, essential elements of these neoplasms), personalised for each patient.
Indeed, for the development of the newly proposed models, patients' surgical specimens
will be initially evaluated by the Pathological Unit and, in the presence of pathological
material in excess not required for the routine diagnostic procedure, it will be employed
for the generation of the proposed personalised models. 3D culture techniques (e.g., 3D
bioprinting) will be used for the development of the models. Moreover, in order to
further mimic in vitro the in vivo environment, the models will be maintained under
dynamic conditions.
These newly proposed models will be exploited for studying the mechanisms underlying
disease development and progression, as well as for performing drug testing.
Criteria for eligibility:
Study pop:
A total number of approximately 70 patients will be enrolled
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
- patients who undergo pancreatic surgical resection for non-functioning pancreatic
neuroendocrine tumor
- age ≥ 18 years
- informed consent
Exclusion criteria:
- non-pancreatic neuroendocrine tumor histological diagnosis
- age < 18 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS San Raffele Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Partelli, MD, PhD
Phone:
0039 02 2643 7697
Email:
partelli.stefano@hsr.it
Contact backup:
Last name:
Cristina Scielzo, PhD
Phone:
0039 02 26436487
Email:
scielzo.cristina@hsr.it
Start date:
January 16, 2024
Completion date:
December 2029
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06121622
