Neoplasms

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Pancreatic Neoplasms

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Gastrointestinal Diseases

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Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Massimo Falconi, Professor

Anna Battistella, MD

Stefano Partelli, MD, PhD

Cristina Scielzo, PhD

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.

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.

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

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

IRCCS San Raffaele

Principal Investigator

Eligible consenting patients will undergo one-time biopsy, during which at least 3 tumors' core samples (total length of at least 6 cm) will be collected. Core tumor biopsies and 3 vials of whole blood and archived tumor specimens will be obtained for genomic testing analysis.

Lillian Siu, MD

Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular profiling.

In this prospective study the aim is to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs). Eligible population includes: NETs and PanNETs patients who have undergone or are undergoing treatment with targeted therapies and have shown prolonged clinical benefit, and NETs and PanNETs patients who have been treated with these agents and just recently progressed. RNA and DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to transcriptome sequencing and DNA sequencing analyses to evaluate possible genes of interest and related targetable pathways. Moreover, archived tumor samples will be requested from all patients to perform additional genomic testing. Remaining RNA and DNA will be banked for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).

Fresh tumor tissue, 3 tubes of whole blood, archival tumor tissue

Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Princess Margaret Hospital, Canada

University Health Network, Toronto

Study title	NCT ID	Conditions	Eligibility	Organization
Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours	NCT06121622	Pancreatic Neur...	18 Years -	IRCCS San Raffaele
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors	NCT02586844	Neuroendocrine ... Pancreatic Neur...	18 Years -	University Health Network, Toronto
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors	NCT02586844	Neuroendocrine ... Pancreatic Neur...	18 Years -	University Health Network, Toronto
Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours	NCT06121622	Pancreatic Neur...	18 Years -	IRCCS San Raffaele
Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours	NCT06121622	Pancreatic Neur...	18 Years -	IRCCS San Raffaele

Spots Global Cancer Trial Database for pannet

Every month we try and update this database with for pannet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pannet

Every month we try and update this database with for pannet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pannet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.